Issue number ∕ date :

Form name : GMP Checklist

Your company logo here Update number ∕ date :
Form Code : F-000
Page : ( ∕ )

Company Name:

Address

Phone Number:

Date:

Contact Person:

Title:

Phone Number:

Questions Response
1.1. GENERAL 3 2 1
1.1.1. General information
1.1.1.1. Is there evidence of registration of the key persons responsible by the Regulatory Authority?

1.1.1.2. Is the qualified person responsible, according to company's organization chart, present at the
time of the inspection?

1.1.1.3. Is there evidence of a license to operate issued by the Regulatory Authority?

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1.1.1.4. Is there a GMP related recalls from the market in last 2 years?

1.1.2. Premises
1.1.2.1. Are there any sources of environmental contamination in the area surrounding the building?
1.1.2.2. If "YES", are protective measures undertaken?
1.1.2.3. Are there approved and up to date layouts for the area?
1.1.2.4. Are toilets located before change rooms?
1.1.2.5. Are there physically separated areas for each production step?
1.1.2.6. Is the flow of personnel and materials shown such that they are unidirectional& prevent
product contamination &mix up?
1.1.2.7. Is there a distinct and separate area for washing
1.1.2.8. Do the flow of cleaned equipment through the washing room don’t allow re contamination?
1.1.2.9. Is there packaging area completely physically separated from processing area?
1.1.2.10. Are drained equipped to prevent back flow?
1.1.2.11. Are the visible electrical installations maintained in good condition?
1.1.2.12. Does the company comply with the national legislation on fire control and prevention?
1.1.2.13. Is waste treatment program covering the entire factory?
1.1.2.14. Is there a special lighting system in the sampling, weighing, processing area in case those
photosensitive raw materials are being handled?
1.1.3. Ancillary area
1.1.3.1. Are there SOP’s for washing uniforms separately depending on the type of area (sterile, non
sterile, maintenance, special products)?
1.1.3.2. Is there a laundry area for uniforms which is separate from production areas?
1.1.3.3. If an outside laundry facility is used, are personnel and the person responsible instructed
about the corresponding SOP?
1.1.3.4. Is this outside laundry facility periodically audited & the audit recorded?

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1.1.3.5. Is there a pure steam generator, if necessary?

1.1.3.6. Is there a compressed air generator free of oil, if necessary?
1.1.3.7. Is there an electricity generator for the maintenance of critical systems and processes to be
used in case of problems with the electricity supply occur?
1.1.3.8. IS it connected to critical equipment as autoclave, lyophilizer …etc?
1.1.3.9. Do its performance tested &the time it starts work after electricity drop is suitable?
1.2. VALIDATION
1.2.1. General aspects:
1.2.1.1. Is there a validation master plan?
1.2.1.2. Is there a validation and re-validation program, and under the responsibility of quality
assurance for approval and follow-up of its activities?
1.2.1.3. Are critically important processes validated?
1.2.1.4. Are the validations performed and documented?
1.2.1.5. Is every important modification to the manufacturing process validated, including any change
in equipment, manufacturing area, materials, changes in raw materials, packing
materials, changes in critical support systems processes and methods that may affect
the quality of the product or reproducibility of the process?
1.2.1.6. In case electronic data processing systems are used, are these validated?
1.2.1.7. If the system automated is a safety back-up kept?
1.2.1.8. Are safety passwords used for system access?
1.2.1.9. Are these passwords only assigned to authorize personnel?
1.2.1.10. Are the validation studies performed according to pre-defined protocols &there is a report?
1.2.1.11. Are trend analyses performed to assess the need to re-validate in order to assure the
processes and procedures continued to obtain the desired results?
1.2.2. CLEANING
1.2.2.1. Is a validation performed to confirm major& minor cleaning effectiveness?
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1.2.2.2. Is the quality of the water used in the final rinse of the same quality of the water used in
production?
1.2.2.3. Does the Validation Protocol include Cleaning SOP’s to be used& clearly defined sampling
points?
1.2.2.4. Is the work of the Operating Personnel effectively supervised?
1.2.2.5. Have acceptance limits been set according worst case?
1.2.2.6. Are detergent residues within limits?
1.2.2.7. Are there Validation Records?
1.2.2.8. Is the Final Validation Report is supported by the signature of all those involved, the
verification by Production and the signature of Quality Assurance?
1.3. STORAGE AREA
1.3.1. Sampling area
1.3.1.1. Is there a physically separated area for sampling?
1.3.1.2. Does the sampling area have sanitary finishes?
1.3.1.3. Does the sampling area has LAF unit ?
1.3.1.4. Does it have change room?
1.3.1.5. Is there a SOP for the cleaning of the sampling area?
1.3.1.6. Is there a place to keep the sampling utensils in an orderly fashion to protect it from
contamination?
1.3.1.7. Is there a washing area, which is separated, for the sampling utensils?
1.3.1.8. Incase no washing room for sampling area; is there a SOP for the handlig&storage of those
sampling utensils to their washing area?
1.3.1.9. Is there a SOP for the incoming of raw materials to sample and their transfer to the
quarantine area after sampling?
1.3.2. Warehouse
1.3.2.1. Is there a receiving area?
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1.3.2.2. Is the receipt of materials documented and recorded?

1.3.2.3. Is a visual inspection done at receipt, to verify damages or integrity of seal and containers,
which could affect product quality?
1.3.2.4. Is each received container labeled upon receipt& label attached to the container body and not
to its removable parts?
1.3.2.5. Does the label contain the following information: Item name and code Supplier name
Supplier's lot number , Total Number of Manufacture date , Expiry date , Internal lot
number , Special storage conditions , Test Date , Retest date ?
1.3.2.6. Are the premises of adequate size according to the needs of the company?
1.3.2.7. Is the quarantine& release area properly identified?
1.3.2.8. Do the storage environmental conditions (including lighting, temperature and humidity)
comply with the established storage requirements?
1.3.2.9. Are there records for the temperature, humidity?
1.3.2.10. Are necessary precautions undertaken for the packaging of finished products that require cold
chain?
1.3.2.11. Are the scales calibrated& checked on a scheduled basis?
1.3.2.12. Are there areas physically separated or systems in place to prevent mix-ups of different
materials and products?
1.3.2.13. Are there procedures for all the operations of this area receipt of goods, movement of
containers, load conditions, dispatches, etc?)
1.3.2.14. Is there Stock control system of materials and products?
1.3.2.15. Are the FIFO /FEFO followed for the use of starting materials?
1.3.2.16. Before release by quality control, are all items and finished products properly identified as
such and maintained in quarantine, either physically or by a system?
1.3.2.17. Are rejected materials properly identified and stored separately in restricted areas?
1.3.2.18. Is there procedure for materials destruction?
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1.3.2.19. Are shelves and/or platforms separated from floors and walls to allow cleaning?
1.3.2.20. Is there a SOP&record for cleaning ware house?
1.3.2.21. Are packages and containers with items (drums, , boxes, etc.) adequately closed?
1.3.2.22. Is there an area which is secure or with restricted access which is used to store labels?
1.3.2.23. Are all outdated printed materials destroyed?
1.3.2.24. Within the storage room, are there distinct areas which are physically separated and with
restricted access for psychotropic and narcotic substances?
1.3.2.25. Is there a SOP dealing with spills of corrosive or toxic and active substances?
1.3.2.26. Are there areas specific for the storage of flammable and explosive Products ,is its
temperature &humidity record comply with the stated on the drums?
1.3.2.27. Is there an area for Finished Product Release?
1.3.2.28. Is there a suitable fire fighting system with record of regular check on it?
1.3.3. Rodent & pest control
1.3.3.1. Is there control for rodent & insects?
1.3.3.2. Is there a map& monitoring record for the rodent and pest control?
1.3.4. Returned/ Recall Product
1.3.4.1. Is there an area that is physically separated and has restricted access for the storage of
returned or recalled products until their fate is determined?
1.3.4.2. Are the products properly identified as such?
1.3.4.3. Are all actions and decision taken recorded?
1.4. DOCUMENTATION
1.4.1. Master formula
1.4.1.1. Is there an updated master formula for each product and size of lot to be manufactured? Do
the Technical Director and/or Quality Control/Assurance Director authorize all master
formulas?
1.4.1.2. If it is necessary to modify the master formula, are there written procedures on how to do
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this?
1.4.1.3. Is authorization from the Health Authority expected before undertaking the change?
1.4.1.4. Do all products have a master formula containing Product name, code and product number?
1.4.1.5. Do all products have a master formula containing Description of pharmaceutical dosage
form, concentration and/or strength of the active ingredients, Product shelf life?
1.4.1.6. Do all products have a master formula containing Theoretical intermediate yield and
theoretical final yields with their correspondent limits?
1.4.1.7. Indication of the areas in which each one of the process steps occur and equipment used?
1.4.1.8. Do all products have a master formula containing Names and signatures of the qualified
people involved in the issuance, review, and approval (at least two)?
1.4.1.9. Do all products have a master formula containing detailed instructions of the steps to follow
for each stage of the process?
1.4.1.10. Do all products have a master formula containing Instructions concerning controls during the
process, of intermediate products and operational variations, indicating specifications?
1.4.1.11. Do all products have a master formula containing In the master formula, are there references
to the SOPs related to different stages of manufacturing, equipment operation, etc.
when they correspond?
1.4.1.12. Do all products have a master formula containing Special precautions that should be taken
during the different stages of the process due to the characteristics of the starting
materials handled and equipment?
1.4.1.13. Do all products have a master formula containing The standards for the storage of the
intermediate or bulks, including the container, the labeling and any other storage
condition when the product requires it?
1.4.1.14. Do all products have a master formula containing Formula review date?
1.4.1.15. Do all products have a master formula containing Forms for record keeping of product
specifications during manufacture process (weight, hardness, friability, closure of

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capsules, disintegration, viscosity, etc.) performed by production and quality control?

1.4.1.16. Is a production order issued for each batch of processed product?
1.4.2. Batch process record
1.4.2.1. Does the batch process record contain the Product name, Issue date, Batch number, Expiry
date of finished product?
1.4.2.2. Does the batch process record contain the list of raw materials involved (including the ones
that are used up during processing) with their code numbers, lot, and/or analysis,
theoretical and real quantities utilized for each of them?
1.4.2.3. If it is necessary to adjust the concentration of raw materials, is the modification signed by a
qualified person?
1.4.2.4. Are the labels of the raw materials separated, attached?
1.4.2.5. Is the detailed description of each one of the steps included in the processed lot record?
1.4.2.6. Are the areas and equipment/lines released recorded?
1.4.2.7. Is the date, the starting and ending time of every step recorded?
1.4.2.8. Are the values of operational deviations to be controlled during process (Ex.: temperature,
pH, times, agitation speeds, etc.) recorded and the acceptance limit indicated?
1.4.2.9. If there are process deviations with regard to the master formula, are they recorded?
1.4.2.10. Whenever there is an IPC in some step of the process, are they recorded?
1.4.2.11. Are the real yields of the intermediate and end stage recorded?
1.4.2.12. Are the yields within the acceptable limits?
1.4.2.13. In case of a deviation, is the cause of the deviation investigated according to the SOP & the
findings documented?
1.4.2.14. Are the signatures/ initials of the people who carry out the different operations and of those
who supervise them recorded?
1.4.2.15. It is verified that the data that should appear on the batch process record are completed at the
time in which each action is undertaken during the process?
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1.4.2.16. Are reprocessing and reworking previously authorized by Control/Quality Assurance & done
in accordance with a SOP?
1.4.2.17. After the manufacture process is ended, is all the documentation that is part of the batch
record, including the certificate of analysis of the Finished Product, filed?
1.4.2.18. Is the file maintained for at least one year after the Expiry date of the lot?
1.4.3. Batch packaging record
1.4.3.1. Is a packaging order for every batch or part batch processed issued?
1.4.3.2. Is the release of areas and equipment/ lines recorded?
1.4.3.3. Does the batch packaging record contain the name of the product, the batch number, the
expiry date of the finished product and the quantity of bulk product to be packed, as
well as the batch number and the planned quantity of the finished product that will be
obtained, the quantity actually obtained, and the reconciliation?
1.4.3.4. Does the batch packaging record contain the date (s) and time(s) of the packaging
operations?
1.4.3.5. Does the batch packaging record contain the initials of the operators of each one of the
different steps?
1.4.3.6. Does the batch packaging record contain the controls undertaken with the outcome of
verifying the identity and conforming to the packaging instructions, including the
results of the inprocess controls?
1.4.3.7. Does the batch packaging record contain Details of the packaging operations carried out,
including references to equipment and the packaging lines used, cleaning records?
1.4.3.8. Does the batch packaging record contain if necessary, the instructions for keeping the
product unpackaged or a record of returning product that has not been packaged to the
storage areas?
1.4.3.9. Does the batch packaging record contain whenever possible, samples of the printed
packaging materials used, including samples bearing the batch number, expiry date

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signed?
1.4.3.10. Does the batch packaging record contain Notes on any special problems, including details of
any deviation from the packaging instructions, with written authorization by the
qualified person responsible?
1.4.3.11. Does the batch packaging record contain the quantities and reference numbers or
identification of all the printed packaging materials and bulk product issued, used,
destroyed or returned to stock and the quantities of product obtained to permit an
adequate reconciliation?
1.4.3.12. Are the reprocessing and reworking of products controlled in a SOP for deviations?
1.4.3.13. After the packaging process is ended, is all the documentation that is part of the batch
packaging record, including the analytical protocol of the Finished Product, filed?
1.4.4. General documentation
1.4.4.1. For each procedure, are the purpose, scope, references, issuing& effective date and
responsibilities clearly defined?
1.4.4.2. Is there the detailed and precise description, in order of the routine operations?
1.4.4.3. Are the procedures available, current?
1.4.4.4. Are the signatures of the personnel that issue, review, and approve the document indicated?
1.4.4.5. Are the records indicated within the procedures available?
1.4.4.6. Does the use of correction fluid or eraser remain clearly prohibited in the documentation?
1.4.4.7. If there are amendments/changes, are the date and signature recorded?
1.4.4.8. Is there a SOP for the handling of changes and deviations?
1.5. NON-STERILE PRODUCTS

1.5.1. Area:
1.5.1.1. Are there adequate changing stages before entering the areas?
1.5.1.2. Is there written instruction with that?
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1.5.1.3. Are changing rooms having the same class as the area they lead to?
1.5.1.4. Are the change rooms designed with air locks?
1.5.1.5. Is a bench of sanitary conditions available?
1.5.1.6. Is the area for washing with a supply of purified water &filtered air?
1.5.1.7. Is a validity period established for cleaned objects?
1.5.1.8. Are personnel responsible for clean toilets &there tools different from who clean
manufacturing area?
1.5.1.9. Are there gauges to detect pressure differentials? Is there a record?
1.5.1.10. Are the walls, floors and ceiling surfaces smooth and easy to clean?
1.5.1.11. Are fixed pipes identified and do they indicate the direction of flow, whenever necessary?
1.5.1.12. If raw materials or the handled products which require it, are the temperature and relative
humidity measured and recorded?
1.5.1.13. Is the IPC room with calibrated needed instruments?
1.5.1.14. Is the area cleaned, as per established Requirements in the cleaning SOP? Is it documented?
1.5.2. Equipment
1.5.2.1. Are the materials used in the construction of the equipment, non reactive with the active
ingredients handled?
1.5.2.2. Are the labels adhered to the containers, equipment, and other auxiliary elements of
production and areas unambiguous &indicate its condition?
1.5.2.3. Are the records of use and maintenance of equipment kept?
1.5.2.4. Are the instruments correctly labeled indicating the validity of calibration?
1.5.2.5. Is the equipment not in use identified as such and removed from the production areas
according to the SOP?
1.5.2.6. Are all the containers, equipment and auxiliary elements cleaned after their use, is it
documented?
1.5.2.7. For fluid bed dryers: is there a set of sleeves for each product, or is there a cleaning
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validation process that guarantees no cross-contamination?

1.5.2.8. Are the integrity, measurements, and identity of the punches confirmed? Are records kept?
1.5.2.9. Is the access to them restricted?
1.5.2.10. Is the air injected in the coating equipment filtered? Is it included in the preventive
maintenance plan?
1.5.2.11. Are the filters used in filtration of liquid disposable? Are the changes recorded?
1.5.3. Operation

1.5.3.1. Is there a confirmation that only one product processed in each processing room?
1.5.3.2. Do personnel in production carry out the verification of the weight of the raw materials used
in the manufacturing of each lot?
1.5.3.3. Are the parameters of the drying operations measured and recorded?
1.5.3.4. Is there assurance that the drying ovens do not receive lots of different products or different
lots from a single product at the same time?
1.5.3.5. Is the transfer of semi manufactured/bulks products between one step of the process and
another carried out in a manner to prevent their contamination?
1.5.3.6. Is there confirmation that the suspensions and/or emulsions are maintained uniform
throughout the bottling process?
1.5.3.7. Do bottles receive some type of cleaning &on line with before filling?
1.5.3.8. In the case of the automatic system, are discarded units which are returned to the line,
previously inspected and approved by authorized personnel?
1.5.3.9. Are process controls performed at each production step?
1.5.4. Validation
1.5.4.1. Is installation of equipment been qualification (IQ)? Is protocols &report produced?
1.5.4.2. Is operation of equipment been qualification (OQ)? Is protocols &report produced?
1.5.4.3. Is performance of equipment been qualification (PQ)? Is protocols &report produced?
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1.5.4.4. Is any deviation in the report of qualification investigated &action is taken?

1.6. STERILE PRODUCTS
1.6.1. Premises, Area Design And Layout:
1.6.1.1. Does the design of the areas, grade A and B, permit a visual view of all the operations from
the outside?
1.6.1.2. Is the preparation environment where a solution is subject to terminal sterilization a grade D
at least?
1.6.1.3. Are sterile products that are to be terminally sterilized, filled in a workstation with laminar
airflow grade A surrounded by class C area?
1.6.1.4. Are products that are sterilized by filtration, is the preparation of the solution in closed tanks
carried out in a grade D environment at least?
1.6.1.5. Are products that are sterilized by filtration; is the preparation of the solution in opened tanks
carried out in a grade C environment?
1.6.1.6. Are sterile filtered products, after the sterilizing filtration process is the product handled and
filled under local grade A conditions within a grade B or C background environment?
1.6.1.7. Is the whole manufacturing process of products prepared with aseptic raw materials, carried
out under local grade A within a grade B environment?
1.6.1.8. Are the wall surfaces, floors, doors and ceilings smooth and impervious, minimizing the
shedding and the accumulation of particles and microorganisms?
1.6.1.9. Are they easy to clean and maintain sanitary?
1.6.1.10. Are the pipes, lighting fixtures, points of ventilation and other services designed in such a
way to permit their easy cleaning and sanitation?
1.6.1.11. Are pipes of dangerous liquids or gases identified and indicate the direction of flow,
whenever necessary?
1.6.2. Changing Rooms:
1.6.2.1. Are there adequate changing stages before entering the sterile areas?
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1.6.2.2. Is the entry of the personnel into the clean rooms with watches, jewelry, or cosmetics
prohibited?
1.6.2.3. Is there written instruction with that?
1.6.2.4. Are there change rooms exclusive for the controlled environment areas?
1.6.2.5. Are changing rooms having the same class as the area they lead to?
1.6.2.6. Are the change rooms designed with air locks& interlocking?
1.6.2.7. If no is there any type of alarm to prevent opening of more than one door in a time?
1.6.2.8. Is a bench of sanitary conditions available?
1.6.2.9. If no is there any alternative measure to separate the dirty zone from the clean one?
1.6.3. Sterile Gowning:
1.6.3.1. Is there an area for the conditioning of the clothes for use in the controlled environments after
its sterilization?
1.6.3.2. Is there a validity period for the gown after sterilization?
1.6.3.3. Is the clothing used appropriate for the areas and tasks that are carried out?
1.6.3.4. Are the uniforms used for work in aseptic areas, clean, in good condition and sterilized prior
to their use?
1.6.3.5. Is there validity time period established for the sterilization of the uniforms?
1.6.3.6. Are protection elements utilized for the operations that require them?
1.6.3.7. If no does this compromise product quality?
1.6.3.8. Is there an exclusive laundry for the sterile area separated from laundry of other department?
1.6.3.9. Are the gloves free of lubricants?
1.6.4. Washing Area

1.6.4.1. Is there an area or sector for the washing of containers and/or tools?
1.6.4.2. Is label attached to cleaned objects showing its status?
1.6.4.3. Is a validity period established for cleaned objects?
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1.6.5. Cleaning, Sanitization and Hygiene:

1.6.5.1. Are the materials and equipment sterilized and their containers sanitized?
1.6.5.2. Are there instructions in the SOP for the cleaning and disinfection of every area?
1.6.5.3. Is the area cleaned, within 24 hours after ending the process activities?
1.6.5.4. Is a validity period established for area cleaning?
1.6.5.5. Are records for cleaning kept?
1.6.5.6. Is there SOP of disinfection showing show type, conc& contact time of disinfectants used? is
there a record?
1.6.5.7. Is there SOP & record for disinfectant preparation and sterilization?
1.6.5.8. Are disinfectant used in alternative basis to prevent resistant strains?
1.6.5.9. Are containers for waste collection identified as such?
1.6.5.10. Are the materials used in containers construction compatible with the active ingredients
handled?
1.6.6. Equipments:
1.6.6.1. Does the location of the equipment facilitate their cleaning, as well as, the cleaning of the
area in which are found?
1.6.6.2. Do the cleaning procedure validated?
1.6.6.3. Is there a log book for every equipment usage?
1.6.6.4. Are there calibration records of the equipment/instruments available?
1.6.6.5. Is the unused equipment removed from the production areas?
1.6.6.6. Is the equipment in repair identified as such?
1.6.6.7. Are all equipment and auxiliary elements cleaned after their use?
1.6.6.8. Is a validity period for the cleaning of the equipment established?
1.6.6.9. Are all the hoses, tubes and pipes used in the transfer of fluids identified?
1.6.6.10. When they are not dedicated, is the cleaning validated?
1.6.6.11. Are the connections and valves used of sanitary conditions?
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1.6.7. Operations
1.6.7.1. Are there flow charts showing the production steps and identify critical points?
1.6.7.2. Are process controls undertaken at the different steps of production?
1.6.7.3. Are records kept?
1.6.7.4. Is there adequate control on maximum number of personnel present in clean and aseptic
area?
1.6.7.5. If sterilizing filtration systems utilized is the integrity of the filters confirmed before
filtration?
1.6.7.6. If the filters used are not disposable, is their usage period established,are the sterilization
number recorded? (NO. of sterilization cycles)?
1.6.7.7. Are the changes recorded?
1.6.7.8. Are the filters dedicated by active raw material?
1.6.7.9. Is the integrity of the filters confirmed after filtration?
1.6.7.10. Are records kept?
1.6.7.11. For each product, is the maximum time between the starting of the preparation of a solution
and its sterilization or filtration through absolute filters established?
1.6.7.12. Are gases used to purge solutions adequately filtered?
1.6.7.13. Is the batch sterilization in more than one cycle, Is it divided to different identified lots for
sterility testing?
1.6.7.14. Are records of time, temperature, and/or pressure of the autoclave and depyrogenation oven
maintained?
1.6.7.15. Are records of sterilization and depyrogenation of the container for the filtrate product
reception available?
1.6.7.16. Is the transfer of intermediate/bulks between one step and another carried out in a manner
which prevents their contamination?
1.6.7.17. Is the maximum time elapsed between the filtration and the product filling determined for
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products without terminal sterilization?

1.6.7.18. Are mix-ups avoided between the sterile and non-sterile material?
1.6.7.19. Is clean steam used in the sterilization cycles monitored to assure suitable quality?
1.6.7.20. Is a validation program for moist heat sterilization cycles performed and recorded?
1.6.7.21. Are indicators used at each cycle of sterilization?
1.6.7.22. Are records kept?
1.6.7.23. Is the product 100% visually inspected?
1.6.7.24. Incase inspected by operators do they a record for periodical medical examination ?
1.6.8. Materials and Components:
1.6.8.1. Do they enter to the aseptic area by air lock?
1.6.8.2. Is there a validity time period established for the sterilization of components, containers of
products in bulk and other equipment?
1.6.8.3. Do the sterilized material and components transferred in a manner to prevent its
contamination or cross contamination?
1.6.8.4. Do leak test is done for ampoules?
1.6.9. Aseptic Process Validation:
1.6.9.1. Is media fill conducted with culture medium, in the working conditions, at least on a
semiannual frequency?
1.6.9.2. Are these tests carried out in such away to most accurately reproduce the normal working
conditions in the area?
1.6.9.3. Are they carried out in a minimum of 3600 units?
1.6.9.4. Are there records of these tests?
1.6.9.5. Are the causes of any detected contamination investigated?
1.6.9.6. Are there records of this investigation?
1.6.9.7. Are there records of the corrective actions taken in those cases?
1.7. QUALITY CONTROL
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1.7.1. Laboratory equipment

1.7.1.1. Does the Quality Control laboratory carry out its own Physicochemical, Microbiological, and
Biological controls?
1.7.1.2. Is a clearly defined flow of samples and documentation established?
1.7.1.3. Are the physicochemical and microbiological controls sector physically separated?
1.7.1.4. Are the physicochemical and microbiological controls sector physically separated from the
production?
1.7.1.5. Is the Quality Control Department responsible for approving or rejecting the raw materials,
packaging materials, intermediate products, and finished products?
1.7.1.6. Are the installations and the equipment as appropriate with the type of manufacture & active
ingredients handled?
1.7.1.7. Is there a defined area for the washing and conditioning of materials exclusively destined for
the physicochemical laboratory?
1.7.1.8. Are there safety installations such as shower, eye washer, fire extinguisher, and protection
elements?
1.7.1.9. Is there the necessary equipment for the analytical controls required for the material &
products?
1.7.2. Stability
1.7.2.1. Does stability study program include a complete description of the product studied?
1.7.2.2. Does stability study program include the controlled parameters and validated analytical
methods that demonstrate the stability of the product in concordance with the
established specifications?
1.7.2.3. Does stability study program include a sufficient number of lots (no less than three)?
1.7.2.4. Does stability study program include timetable of the analytical tests to carry out for every
product?
1.7.2.5. Does stability study program include the accelerated &real time stability?
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1.7.2.6. Does stability study program include sufficient quantities of samples in order to fulfill with
the program?
1.7.2.7. Is there a summary and obtained data including the evaluations and study conclusions?
1.7.2.8. IS there a record of monitoring of the marketed products that makes it possible to confirm
that, if the conditions of storage are met, the product maintains its quality during its
validity period?
1.7.3. Validation
1.7.3.1. Does the Validation Master Plan include the Quality Control laboratory?
1.7.3.2. Does the laboratory have equipment qualification protocol&report?
1.7.3.3. If there is deviation in the qualification is it investigated &corrective action taken? is that
recorded ?
1.7.3.4. Is there a validation program for those analytical methods not published by internationally
recognized pharmacopoeias?
1.7.3.5. Are there documents supporting compliance with this procedure?
1.7.3.6. Are analytical methods verified when despite being coded by internationally recognized
pharmacopoeias, these are performed differently to the coding?
1.7.4. Sampling procedure
1.7.4.1. Are there SOPs with the detailed description for the sampling of Raw materials, Packaging
materials, intermediate, finished product?
1.7.4.2. Are there sampling plan for raw,packging,intermediate &finished product ?
1.7.4.3. Are all incoming packaging materials, without exception, sampled by Quality Control in
accordance with the established standard& sampling plan?
1.7.4.4. Are the sampling elements duly stored and labeled?
1.7.4.5. Is there a written procedure for the cleaning, use, and conservation of the sampling eleme
1.7.5. Analytical method
1.7.5.1. Are the analytical methods utilized authorized by the one responsible of Quality Control?
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1.7.5.2. Are there specifications for Raw materials, Packaging materials, Intermediate, finished,?
1.7.5.3. Are there records that Quality control checks if each manufactured lot meets the established
specifications?
1.7.5.4. Is there SOP for out of specification?
1.7.5.5. Are there records of this investigation &action taken?
1.7.5.6. Do the records of the tests contain Sample identification, Date, Name of the analyst,
Identification of the reference standard, Parameters and conditions that correspond?
1.7.5.7. Do the analysts have a serial logbook in which are recorded the laboratory results?
1.7.5.8. Are the calculations dated and signed by the analyst?
1.7.5.9. If there are observed modifications of data, is the amendment carried out dated and signed?
1.7.5.10. Does the amendment make possible to visualize the original datum?
1.7.5.11. In the records of the analyses, it is indicated: Name of the analyzed material, Lot number ,
Analysis number ,Obtained results , Date , Utilized methods and specifications ,
Signs/ initials of the people who carried out the test , Sign/initials of the person that
verified the tests and calculations ?
1.7.6. Retained samples

1.7.6.1. Are samples of retention of the active raw materials and finished products, in enough
quantity to carry out all the tests by duplicate, kept in accordance to a SOP?
1.7.6.2. Are the retention samples of finished products kept until a year after the expiry date of the
product?
1.7.6.3. Are the samples of retention of raw materials kept until a year after the expiry date of the last
lot of product prepared with them?
1.7.7. Reference standard
1.7.7.1. Are there standards and reference materials?
1.7.7.2. Is a record of the primary standards kept?
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1.7.7.3. Is a record of the secondary standards kept?

1.7.7.4. Is a record of the reference materials kept?
1.7.7.5. Does the company have primary standards, coded by Pharmacopoeias or internationally
recognized agencies, for each active ingredient?
1.7.7.6. Do all the secondary standards and reference materials have current analytical certificate?
1.7.7.7. Are there SOPs for the preparation, use and conservation of standards and reference
materials?
1.7.7.8. Are those procedures fulfilled?
1.7.7.9. Are the records shown?
1.7.7.10. Does the company have impurities and related substances standards, officials or non-
officials, especially for those considered toxic?
1.7.8. Reagents
1.7.8.1. Are the reagents correctly labeled?
1.7.8.2. Are volumetric solutions used?
1.7.8.3. Is there a standard operating procedure for the preparation, use, and conservation of
volumetric solutions?
1.7.8.4. Is there log book for the preparations of the reagent preparation include Name of the analyst,
Name of the reagent, Calculations, Date of the preparation & expiration?
1.7.8.5. Do every container of analytical solution have a label where there is indicated: Name of the
solution Concentration - standardization factor Preparation date, Responsible, Retest
date, expired date, Storage conditions, Safety category, Reference to the SOP?
1.7.8.6. Are the unstable reagents labeled with reception date, opening date and Expiry date?
1.7.9. Microbiology laboratory
1.7.9.1. Does the company have separated areas for sterility test and other microbiological controls ?
1.7.9.2. Is there any change room before entering the microbiology laboratory?
1.7.9.3. Is there any change room before entering the areas for sterility test?
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1.7.9.4. Is there sop for the cleaning & disinfectant of the change room?
1.7.9.5. Are there proper areas and laminar flow for carry out the sterility tests?
1.7.9.6. Are the filters of the laminar flow periodically checked?
1.7.9.7. Are the materials, culture media and reagents within the validity period?
1.7.9.8. Are the dehydrated culture media stored in the conditions of humidity and temperature
indicated by the manufacturer?
1.7.9.9. Are the parameters of every sterilization cycle of culture
1.7.9.10. Is there separated LAF cabinet to perform growth promotion test?
1.7.9.11. Is the growth promotion test carried out whenever new lots of culture media are utilized?
1.7.9.12. Is negative control test done in accordance with every sterility test?
1.7.9.13. Is a standard operating procedure for the preparation of culture media?
1.7.9.14. Are there microbial reference strains?
1.7.9.15. If there are reference strains, are they certified by an internationally recognized agency?
1.7.9.16. Is there a record of identification and use of strains?
1.7.9.17. Are sterility tests carried out?
1.7.9.18. For sterility tests, are coded methods utilized?
1.7.9.19. If the lot fails the sterility test, is it follow OOS ?
1.7.9.20. Are antibiotic potency assays carried out?
1.7.9.21. Does the company have areas or sectors assigned for the sample Preparation?
1.7.9.22. Does the company have areas or sectors assigned for the washing and Conditioning of
materials?
1.7.9.23. Does the company have areas or sectors assigned for the preparation of culture media?
1.7.9.24. Does microbiology sector have equipment for bacterial decontamination?
1.7.9.25. Is there a procedure for the handling and disposal of chemical and microbial waste?
1.7.9.26. Does the procedure indicate that should not be permitted the accumulation of discarded
materials?
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1.7.9.27. Does Quality control carries out environmental microbiological controls?

1.7.9.28. Are there records?
1.7.9.29. Are tests of bacterial endotoxins carried out in raw materials and goods declared as pyrogen-
free by the supplier, to be used in the injection manufacture?
1.7.9.30. Are tests of pyrogens or bacterial endotoxins carried out in the finished products for
injection?
1.7.9.31. Is an official method utilized for bacterial endotoxin control?
1.7.9.32. Is the method validated?
1.8. QUALITY ASSURANCE
1.8.1. General
1.8.1.1. Is there in the company a quality assurance system?
1.8.1.2. If the documentation is carried out through electronic data processing methods does the
company kept a reserve copy of the documentation?
1.8.1.3. Is the admission of new data or modifying of the existing data in the computer system done
only by the people authorized?
1.8.1.4. Is a record of the data modifications and/or elimination kept?
1.8.1.5. Are the records of lots electronically filed protected?
1.8.1.6. Is there a program of control of the SOPs?
1.8.1.7. Does Quality assurance is responsible of release of every batch is that indicated in a SOP ?
1.8.1.8. If in the review of the production records are detected bypasses of the established procedures,
is quality assurance responsible for ensuring a complete investigation of the bypasses
and that the final conclusions are justified?
1.8.1.9. If a lot does not meet specifications, does the investigation is extended to other lots of the
same product and of other products that could have had some relation with the defect or
the discrepancy?
1.8.1.10. Does the company kept originals of all procedures and records of distribution of the
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authorized copies?
1.8.1.11. If a procedure is modified, is there a system by which the accidental use of a previous version
is prevented?
1.8.1.12. IS there a SOP for change control? is it fullfield?
1.8.1.13. Is there a SOP for annual product review? Is that FULFILED?
1.8.1.14. Is there a SOP for corrective &preventive action?
1.8.2. Preventative maintenance& calibration program

1.8.2.1. Is there a program for preventive maintenance for all the equipment, premises ,utilities?
1.8.2.2. Are there records that shown preventive maintenance program compliance?
1.8.2.3. Is there a program of equipment calibration?
1.8.2.4. In the equipment calibration program is indicated, which operations are performed internally
and which by contracted services?
1.8.2.5. Is the frequency of calibration indicated in the equipment calibration program?
1.8.2.6. Are records of calibration of each equipment that shown program Compliance?
1.8.2.7. Are there written procedures to perform the calibration of each equipment?
1.8.2.8. Is the equipment correctly labeled indicating the calibration validity?
1.8.2.9. In case of internal calibrations, does the laboratory have certified standards?
1.8.2.10. Are the corresponding certificates shown?
1.8.3. QUALITY AUDITS/ SELF-INSPECTIONS
1.8.3.1. Are quality self-inspections and/or audits carried out?
1.8.3.2. Is Quality assurance responsible for the coordination of quality self-inspections and/or
audits?
1.8.3.3. Are the self-inspections/audits carried out with a pre-established plan?
1.8.3.4. Are the necessary corrective taken with in the time limit specified?
1.8.3.5. Do the written instructions of quality self-inspection/ audits include the entire factory?
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1.8.3.6. Are the Results of previous self-inspections and adopted corrective measures documented?
1.8.3.7. Does the report issued once finished the self-inspection contain the Results of the self-
inspection?
1.8.3.8. Does the report issued once finished the self-inspection contain evaluation and conclusions?
1.8.3.9. Does the report issued once finished the self-inspection contain corrective measures
recommended?
1.8.3.10. Is the monitoring of the corrective measures carried out?
1.8.4. SUPPLIERS QUALIFICATION
1.8.4.1. Is there a record of approved suppliers available for the areas that require it?
1.8.4.2. Is there a program for evaluation and audits to suppliers?
1.8.4.3. Is it fulfilled?
1.8.5. RECALL
1.8.5.1. Is there A sop to recall products from the local and international market, if necessary?
1.8.5.2. Is there a responsible person (independent from the marketing department) designated by or
in accordance with the qualified person responsible for the coordination and execution
of the recall procedure?
1.8.5.3. Is Quality control/Quality assurance/Regulatory Affairs notified of undertaken recall
operations?
1.8.5.4. Does the procedure indicate the mandatory requirement of notifying the Health Authority
immediately in the event that the cause is for health reasons?
1.8.5.5. In the case of having distributed products to other countries, is the Health Authority of the
recipient country and the recipient of these products informed immediately?
1.8.5.6. Are distribution records available for a prompt recall of products from the market?
1.8.5.7. Is there a classification of recall?
1.8.5.8. Is there an updated list of contact persons of the distributors?
1.8.6. COMPLAIN
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1.8.6.1. Is Quality assurance responsible for coordinating the reception and the monitoring of the
received complain?
1.8.6.2. Is there a responsible person assigned?
1.8.6.3. Are there written procedures for the reception and investigation of the complain?
1.8.6.4. Is record of the complain kept?
1.8.6.5. If necessary, is analytical control made?
1.8.6.6. Do the decisions &corrective action made concerning the complaints remain documented, in
the lot records?
1.9. PACKAGING:

1.9.1. OPERATION:
1.9.1.1. Is the mix-up of different products or different lots of same product avoided by having
physical separation among the packaging lines?
1.9.1.2. Do all finished products have a printed batch number and an expiry date on their primary
container?
1.9.1.3. Is the printed information resistant to fading or erasing?
1.9.1.4. If automatic machines are used to control dimensions, weights, labels, prospects, bar code,
etc., is their proper performance verified?
1.9.1.5. If the review/verification of product done visually, Is there a changeover of staff?
1.9.1.6. If it is done automatically is it challenged for its performance ?
1.9.1.7. Are conditions of lighting and contrast for the review/verification controlled?
1.9.1.8. Are the containers that contain the already inspected material labeled as such?
1.9.1.9. Are the right batch number and expiry date confirmed by authorized personnel?
1.9.1.10. Are precautions taken on dispensing labels to prevent mix-ups?

1.9.2. DOCUMENTS:
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1.9.2.1. Does the company have packaging orders with A full list of all packaging material required
for a normal size batch, including quantities, sizes and types, with the lot number, code
or reference number related to specifications for every packaging material?
1.9.2.2. Does the company have packaging orders with Details concerning process control with
instructions for the sampling and acceptable limits?
1.9.2.3. Is there a SOP available for the process of the return of unused non-coded printed material to
the warehouse?
1.10. HVAC SYSTEM
1.10.1. GENERAL
1.10.1.1. Do they have an air supply filtered by HEPA terminal filter in the areas grade A, B and C?
1.10.1.2. Is the filters efficiency is adequate for such classes?
1.10.1.3. Do grade D areas have high efficiency filters?
1.10.1.4. Is the filters efficiency is adequate for such classes?
1.10.1.5. In the areas of controlled environment (grade B, C and D), is the number of air Changes by
hour is sufficient for such areas?
1.10.1.6. Are the integrity and the sealing of the filters confirmed?
1.10.1.7. Is there a SOP for the review and changing of filters?
1.10.1.8. Are there records?
1.10.1.9. Do the areas have instruments with current calibration, which make it possible to confirm a
cascade of pressure differential?
1.10.1.10. Are there records?
1.10.1.11. Do the air flow patterns prevent contamination?
1.10.1.12. Is there an alarm system that indicates a deviation in the air supply to the aseptic areas?
1.10.1.13. Is there a SOP for how to proceed in the event that this occurs?
1.10.1.14. Is there a measure in place to avoid a conveyor belt going from a grade B area to one of
lower air quality?
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1.10.1.15. Are the actual results complying with the designed criteria?

1.10.1.16. Are there air locks between different classes?

1.10.1.17. Is there a reasonable upgrading of area cleanliness from black, grey, clean area?

1.10.1.18. Are the toilets air not returned or mixed with production air?

1.10.1.19. Is there ventilation with adequate temperature, humidity, and air filtration, if the raw
materials and/or handled products require it?
1.10.1.20. Are the temperature and relative humidity measured and recorded?
1.10.1.21. Are pressure differential values in the different areas measured and recorded?
1.10.1.22. Are records kept?
1.10.1.23. Are particulate counts conducted in the controlled environments?
1.10.1.24. Are records kept?
1.10.1.25. Is the frequency for performing the test in different classes suitable?
1.10.1.26. Are microbiological controls conducted in the controlled environments?
1.10.1.27. Are records kept?
1.10.1.28. Is the frequency for performing the test in different classes suitable?
1.10.1.29. Are air conditioning and/or ventilation systems for each area in accordance with the
operation to be carried out?
1.10.2. Validation:

1.10.2.1. Is the system installation has been qualified & a protocol with a report has been produced?

1.10.2.2. Is the system operation has been qualified &a protocol with a report has been produced?

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1.10.2.3. Is the system performance has been qualified &a protocol with a report has been produced?

1.10.2.4. Does DOP test done in the performance qualification?

1.10.2.5. Is the air velocity in grade A has been measured?

1.10.2.6. Is a preventive maintenance program has been produced from the qualification?

1.10.2.7. Is any deviation during qualification investigated &a corrective action taken to close the
case?

1.11. PERSONNEL

1.11.1. General
1.11.1.1. Is there an updated organization chart of the company?
1.11.1.2. Is there a description of the responsibilities and functions of production and quality control
personnel?
1.11.1.3. Are the responsibilities of production and quality control personnel independent of each
other?
1.11.2. Training
1.11.2.1. Is there a program for on job training & GMP, including specific training appropriate to the
duties assigned to them?
1.11.2.2. Is there a program for refreshment training on GMP, including specific training appropriate
to the duties assigned to them?
1.11.2.3. Are the training records for the personnel in charge of cleaning, if in-house personnel,
shown?
1.11.2.4. Is the Operating Personnel trained by Quality Control on sampling methods (swabs, piece of
fabric, rinsing, placebo)?
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1.11.2.5. Is there documented evaluation for the training?

1.11.3. Gowning
1.11.3.1. Are the personnel using the appropriate uniform for the specified area?
1.11.3.2. Is there a SOP dealing with the use of proper clothing for other persons who enter production
areas (technical service/maintenance, cleaning personnel, quality control inspectors,
quality assurance inspectors, and visitors)?
1.11.4. Medical check
1.11.4.1. Are the personnel required to undergo a medical examination prior to being employed?
1.11.4.2. Is there a procedure to prevent any person who has an apparent illness from entering areas in
which they may adversely affect the quality of the product or affect their own health?
1.11.4.3. Are frequent ophthalmologic examinations conducted on the workers in charge of the
review/verification?

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