CHECKLIST FOR INSPECTION OF MANUFACTURING UNITS

OF ALTERNATIVE MEDICINES AND HEALTH PRODUCTS

1. Date of Inspection…………………………………………………………………………….

2. Name of Manufacturing Unit………………………………………………………………….

3. Complete Address……..………………………………………………………………………

4. Name of Managing Director ……….………………………………………………………..

5. Name of Proprietor (s) / Partner (s) …………………………………………………………..

6. Tel. No. ……………………... Fax No. ……………………..Cell No. …..………………...

Email ……………………………. Website ………………………………..
7. Category of products intended to be manufactured :
(a) Alternative Medicines (Specify whether Homoeopathic / Biochemic or Unani / Herbal
(b) Health Products (Specify whether Food Supplements / Nutritional Products / Baby Milk
and Food & / or Medicated Cosmetics)

8. Technical Personnel :
(a) Name of Production In charge with qualification and experience ………………………..
.…………………………………………………………………………………………….
(b) Names, designation, qualification and experience of other technical personnel in
production ………...………………………………………………………………………
………………………………………………………………………………………………
(c) Name of Q.C In charge with qualification and experience …………………………………
……………………………………………………………………………………………….
(d) Names, designation, qualification and experience of other technical personnel in Q.C
………………………………………………………………………………………………
………………………………………………………………………………………………
(e) Training received by technical personnel, its periodicity and documentation ……………..
………………………………………………………………………………………………
S. No. Facility / Activity Observation
Yes No
1. FACTORY PREMISES
Is layout plan with flow & covered area, attached?
1.1 Does manufacturing unit has adequate space for
receiving and storing raw materials and the areas
given below?
1.2 Manufacturing process areas.
a……………………………
b………………………………..
c……………………………….
d……………………………….
………………………………..
Is list of machinery and equipments in each section
attached?
1.3 Does the Quality Control Section has its own testing
facilities and adequate space for:
a) Chemistry lab.
b) Pharmacognosy Lab.
c) Microbiology Lab.
d) Any other facility, if required
e) Is list of instruments and equipments in QC
attached?
1.4 Office Rejected goods/drugs store
2. LOCATION AND SURROUNDINGS.
2.1 Is the establishment located away from
environmentally polluted areas?
2.2 Is the establishment located away from areas adjacent
to open sewerage, drain/public lavatory or any factory
 which produces excessive, disagreeable odor?
2.3 Are sewage, trash and other effluent disposal
provided?
3. BUILDINGS.
3.1 Do the internal design and layout of establishment
permit good hygiene practices including protection
from cross- contamination?
3.2 Are surfaces of walls, partitions and floors made of
impervious materials and capable of being kept clean?
3.3 Do walls and partitions have smooth surfaces?
3.4 Are floors constructed to allow adequate cleaning and
drainage?
3.5 Are doors, windows, ceiling and overhead fixtures
constructed and finished to minimize buildup of dirt,
condensation and shedding of particles and easy to
clean?
3.6 Are working surfaces that come into direct contact
with drugs of sound condition, durable and easy to
clean, maintain and disinfect?
3.7 Are fire extinguishers or other appropriate system
available and effective ?
3.8 Are any products other than alternative medicines
manufactured in the same building?
3.9 Is there adequate space for equipment, materials and
movement of personal and materials?
3.10 Is there any programme / system to inhibit the entry
of birds, rodents and insects?
3.11 Are lightening and ventilation adequate?
3.12 Are facilities for changing street clothes, footwear,
washing and toilets adequately and
satisfactorily maintained?
3.13 Is the space for drying of raw materials satisfactory?
4. WATER SUPPLY

4.1 Is there adequate supply of potable water?

4.2 Does the potable water meet the specifications
published API specifications?
4.3 Is only potable water used in alternative medicines &
health products?
4.4 Nature of water purification system
5. DISPOSAL OF WASTE

5.1 Are drainage and water disposal systems designed,

constructed and maintained in such a way as to avoid
contamination of alternative medicines & health
products?
5.2 Are the waste water and residues disposed of after
suitable treatment as per guidelines of pollution
control authorities?
5.3 Disposal of solid/ semisolid waste, sewage and liquid
laboratory waste?
5.4 Disposal of Management of gaseous pollutants?
5.5 Is efficient treatment plant in existence / if yes, give
comment on it?
5.6 Are fume hoods of adequate design in existence and
used wherever necessary?
6. CLEANING OF CONTAINERS

6.1 Is there proper arrangement for washing, cleaning and

drying of containers?
6.2 Is this area separated from manufacturing area?
7. STORES

7.1 Is there independent adequate space for storage of

different types of materials such as raw material,
packaging materials and finished products?
7.2 Are alternative medicines & health products storage
facilities designed and constructed to permit adequate
maintenance and cleaning?
7.3 Avoid pest ace and harborage?
7.4 Enable medicines to be effectively protected from
contamination?
7.5 Provided the necessary environment to prevent
spoilage?
7.6 Are storage facilities deigned, constructed and
maintained to ensure that malicious or accidental
contamination of alternative medicines or health
products with harmful materials is prevented?
8. RAW MATERIALS STORES

8.1 Are raw materials or ingredients checked for

parasites, undesirable microorganisms, pesticides or
decomposed or extraneous substances?
8.2 Are raw materials or ingredients inspected and tested
before processing?
8.3 Are raw materials or ingredients subjected to effective
stock rotation?
8.4 Is the area adequate?
8.5 Are the ventilation and lighting of stores adequate?
8.6 Is the raw materials store segregated for different
types of raw material?
a) Raw materials of metallic origin
b) Raw materials of mineral origin
c) Raw materials of animal source
d) Fresh herbs, dry herbs or plant parts excepients etc.
e) Volatile oils/perfumes and flavours
f) Plant extracts and exudates /resins
 g) Others
8.7 Is special area with special condition provided for
special raw materials?
8.8 Are there labels for material of different status i.e.
quarantine, tested and releases for use and rejected?
8.9 Are these labels of different colours?
8.10 Are labels on containers of raw materials to be
used in manufacture checked with regard to
identity, quantity and QA approval?.If not give detail.
8.11
8.12 Is the following information available on the
labels?
1) Name of material
2) Batch Number
3) Analysis number
4) Date of release/ rejection?
5) Date of testing?
6) Date of expiry?
8.13 Is the sampling performed by quality control
personnel?
8.14 Are there sampling procedures?
8.15 Are the containers provided for storage of raw
materials suitable to preserve the quality?
8.16 Is exterior storage available for solvent storage area?
8.17 Available of inflammable materials storage area?
8.18 Whether safety measures provided have been assessed
by regulatory agency if any?
8.19 Is SOP’s available for handling of these materials?
8.20 Are SOP’s for cleaning of containers and closures
available before packing of products?
8.21 Is the dispensing area segregated?
8.22 Are lighting and ventilation adequate?
8.23 Is the area clean?
8.24 Do the personal wear appropriate clothing?
8.25 Is there danger of cross contamination during
dispensing?
8.26 Are the scales and balance calibrated regularly and
record maintained?
8.27 Are the containers of the raw materials to be
dispensed, cleaned before opening?
8.28 After dispensng, are these containers sealed?
8.29 Are the raw materials for each batch, after dispensing
properly identified and checked?
8.30 Are adequately cleaned and dried equipment used for
dispensing materials from the containers?
8.31 Is FIFO principle adopted?
9 PACKING MATERIALS
9.1 Is the area adequate with reference to packing
materials?
9.2 Are the containers and closures adequately cleared
and checked?
10 FINISHED GOODS STORES.
10.1 Is the area adequate with reference to materials
stored?
10.2 Are lighting and ventilation adequate?
10.3 Are there available inventory record to show?
Quantities,
Batch number,
Date of receipt, and other required information.
10.4 Has the distribution record been maintained?
10.5 Does distribution record provide sufficient
 information for drug recall purpose?
10.6 Is there segregation area for retrieved goods?
10.7 Is record available for the retrieved goods?
10.8 Is there any marked quarantine area?
10.9 Is there space for materials requiring special
storage conditions (environmental conditions), if
required?
10.10 WORKING SPACE
10.11 Is space adequate as per manufacturing operations?
10.12 Is machinery along with working manual orderly
placed with adequate space?
10.13 Are there adequate precautions to check cross
contamination?
10.14 HEALTH, CLOTHING, SANITATION AND
HYGIENE OF WORKERS
10. 15 Are workers free from contagious disease?
10.16 Are workers properly uniformed?
10.17 Are there separate lavatories for men and
women?
10.18 Is there provision for changing their cloth and to keep
personal belongings?
10.19 Are adequate facilities like wash-basin with running
water hand drier & clean towels, etc., available for
personal hygiene before entering into production
area?
10.20 Are SOPs available for personnel to observe
personal hygiene?
10.21 Are hygiene instructions displayed in change rooms
and strategic locations?
10.22 Is the sanitation system monitored for effectiveness?
10.23 Is the sanitation system periodically verified by
inspections?
10.24 Is microbiological sampling of environment and
AM&HP contact surfaces carried out?
10.25 Is the sanitation system regularly reviewed and
adapted to reflect changed circumstances?
11 MEDICAL SERVICES
11 .1 Is medical file of each worker maintained separately?
11. 2 Is recruitment of an employee preceded by medical
examinations?
11. 3 What is the periodicity of subsequent medical
examinations?
11. 4 Is an employee whose state of health is doubtful
immediately removed from work site until he is fully
recovered?
12 MACHINERY AND EQUIPMENT
12. 1 Is manually operated or semi-operated or automatic
machines are used for crushing, grinding,
powdering, boiling, mashing, burning, roasting,
filtering, drying, filling, labeling and packing?
12. 2 Are equipment and containers coming into contact
with alternative medicines or health products
designed such that they can be adequately cleaned,
disinfected and maintained?
12.3 Are equipment made of nontoxic materials?
12. 4 Is equipment used to cook, heat, treat, cool and store
designed to achieve the required temperature as
rapidly as necessary?
12.5 Are equipments used to cook, heat, treat, cool and
store designed to monitor and control the required
 temperature?
12.6 Are containers for waste suitably identified?
12.7 Are containers for waste closable to prevent malicious
or accidental contamination of Alternative Medicines
or Health Products?
12.8 Is the equipment adequate for intended use?
12.9 Is it constructed in such a way that lubricants, coolant,
etc. cannot contaminate the drug product?
12.10 Does the equipment permit cleaning and
maintenance?
12.11 Does the equipment show its status i.e. clean, dirty,
batch contents etc?
12.12 Do all apparatus /equipment bear appropriate
labels to identify the product for which the
equipment is used, its batch no., date of
manufacturing etc?
12.13 Are SOPS available for cleaning, maintenance and
sanitation of major equipment?
12.14 Are log books maintained for cleaning, maintenance
and sanitation of major equipment?
12.15 Are SOP’s readily available to operators?
12.16 If automatic electronic or mechanical equipment is
used are there written programs for calibration/
inspection?
12.17 Checks to ensure that changes are made only by
authorized persons
12.18 Are suitable closures or lids available to protect the
changes in properties of materials exposed to outside
atmosphere?

13 BATCH MANUFACTURING RECORD

13. 1 Are appropriate records of processing, production and
distribution kept?
13. 2 Are SOP’s available for the following?
1) Receipt of raw materials and other
components?
2) Quarantine and storage?
3) Quality control system and approval/rejection
4) Release for production
5) In process testing and control
6) Finished products?
7) Storage of finished products?
8) Distribution returned goods
9) Recalls and complaints
10) Cleaning and maintenance?
11) Quality control of water
12) For reworking of non-conforming batches
in existence?

13.3 Are there additional documents like log books, note

books or other similar records available to show
execution of various functions?
13.4 Are there record of receipts of materials and do these
have following information?
13.5 Goods Receipt Note (GRN) and GRN documents
 number?
13.6 1) Date of receipt?
2) Supplier?
3) Manufacturer?
4) Manufacture’s batch number?
5) Type and size of containers?
6) Number of containers and conditions?
7) Are specifications available for all
materials?
8) Are test methods validated?
9) Are periodic reviews of specification
carried out to ensure compliance with new
/revised recognized international
pharmacopoeia?

13.7 Are there record of stock and issue of raw materials

and do these have following information:
1) Opening balance?
2) Date of receipt?
3) Quantity received?
4) Name and batch number assigned by the
manufacturer?
5) Invoice number, date, name and address of
supplier?
6) Analysis receipt no. and date?
7) Date of expiry, if any?
8) Name and batch number of product for
manufacture for which issued?
9) Balance?
10) Signature of issuing person?
13.8 Are there master formulation record for each drug
 product being produced?
13. 9 Is there a separate master production documents for
each dosage form/batch size?
13. 10 Are there master production record signed and dated
by competent person?
13.11 Is batch production record prepared for every batch
produced?
13.12 Is it reproduction of the appropriate master production
documents or it has all critical information about the
batch?
13.13 IS batch record retained for at least one year after
expiry date?

13.14 Has it been checked for accuracy, signed and dated by

a responsible person?

13.15 Is the record maintained by QC for all the tests carried

out?
13. 16 Does the record include?
 1) The name of the product
2) Number of the batch being manufactured?
3) Issue slip with lab ref. No. and Job cards?
4) Graphs, chart, spectra, etc?
5) List of major equipment used?
6) In-process testing reports?
7) Calculations of yield?
8) Notes on deviations with signed
authorization?
9) Signature of individuals of who performed
the tests?
10) Material returns to store slip?
11) Lab report of final product?
12) Review of results for any raw material issued
under “positive Recall”?
13) Signature of the designated person responsible
for the review of records for accuracy and
compliance with established standards?
14) Are other associated records available?
15) Is documentation available readily for
examination?
16) Is batch production record capable of giving
complete history of the batch right from the
raw materials stage to the distribution of
finished products?

14 DISTRIBUTION RECORD

14. 1 Is record of sale and distribution of each batch of

alternative medicines maintained?
14. 2 Is record maintained at least up to 5 years of the
exhausting of stock?
15 RECORD OF MARKET COMPLAINTS
15.1 Are the firms maintaining a record of complaint
received from market?
15 .2 Does the firm has investigated the complaint and has
taken any corrective action?
15.3 Does the firm has intimated such complaint six
monthly to the Authority?
15.4 Does the firm maintain register of any ADR report
received?
15.5 Are written procedure available for receipt and
control of return products?
15.6 Are returned or salvaged drug products destroyed
unless QC determines their reprocessing?
15.7 Are records of the returned products maintained
including their disposition?
15.8 Is a safety manual available?
16 QUALITY CONTROL
16.1 Is the QC area adequate?
16. 2 Has Quality Control section minimum of in-process
controls.
16.3 Are master control procedures signed and stated by
authorized persons?
16. 4 Do these control procedures include specifications,
test procedures or other control procedures for:
16.5 1) Raw materials
2) In process materials
3) Packaging and labeling materials?
4) Finished products?
16. 6 Are the procedures in written form and readily
available for acceptance of reprocessed material?
16.7 Do these control procedures include specifications
test procured or other control procedures for
1) Raw materials
2) In process materials
3) Packaging and labeling materials
4) Finished products?
16.8 Are samples collected by QC personal per SOP
16.9 Is there special room for microbiological and sterility
testing?
16.10 Is the environment of room controlled?
16.11 Are only materials, containers and appliance
necessary for the job in handstored in the vicinity of
the manufacturing areas and are these properly
labeled with name of the product, batch no. date etc.?
16.12 Are all raw materials, containers, closures, labels and
printed packaging material approved and released by
QC for use in manufacture of drugs products
16.13 Are in-process controls carried out by QC personnel?
16.14 Are semi-finished products tested for appropriate
tests when necessary?
16.15 Is bulk finished product tested for established
specifications before packing?
16.16 Is every finished product tested for established
specifications before release for sale?
16.17 Does the QC maintain record of all the tests
carried out?
16.18 Does the QC review all production and control
 record to ensure compliance with established written
procedures before a batch of the product is released
for sale?
17 Reference standards:
17.1 Are standards (R.S) available?
17.2 Are these RS or working standards (WS)?
17.3 Are WS standardized against RS or CRS?
Are quality control procedures validated?
17.4 Are RS stored properly (at appropriate
temperature under dehumidified
conditions)?
17.5 Are record of R.S and their standard maintained?

17.6 Are samples insufficient quantity for testing twice

retained of starting materials and finished products for
future examination, in case of need?
17.7 Is a written program available for stability including
the following?
17.8 Sample storage room temperature?

17.9 Sample size and test intervals?

17.10 Reliable and specific test methods?

17.11 Testing in the same containers closure system in

which it is marketed?
17.12 Date of manufacture and expiration date if any?

17.13 Establishment of in-house specification? –

17.14 Does the firm provide the equipment as
recommended in Part II C ?
18 REQUIREMENT FOR STERILE PRODUCT?
18.1 Manufacturing areas
18.2 Is there separate manufacturing area?
18.3 Are there air locks for entry
18.4 . Is there dust free and ventilated air supply?
18.5 Precautions against contaminations and mix.
18.6 Are manufacturing operations being carried out in a
separate block of adequately isolated building
18.7 Is there appropriate pressure differential in the
process area.
18.8 Is suitable exhaust system provided?
18.9 For aseptic manufacturing proper air supply
(filtered through HEPA) provided?
19 MASTER FILE
19.1 Is master file prepared by the
Manufacturer?

Names of the dosage forms having the required facilities

…………………………………………………………

………………………………………………………..

1. Name & signature of Production In-charge.

2. Name & signature of QC In-Charge.

Comments of the Managing Director/General Manager

……………………………………………………………
Name & Signature of Managing Director/General Manager

Stamp & Seal

Concluding Remarks and Recommendations of the Inspecting Panel

Name, Designation & Signature of Inspecting Panel Member

1.

2.

3.