GOOD MANUFACTURING PRACTICES IN PHARMA INDUSTRY

cGMP TREE
CVMP
Kiran Kota

Design, Build & maintain

facilities & Equipment
Uncover the facts GMP Guidelines Incident Investigation Change management
Complaints, Recall
GMP as per Schedule "M" management
(www.cdsco.nic.in)
Validate the work Be competent Product quality review
GMP as per WHO
(www.who.int) Self Inspection

Document the work 10 Commandments GMP as per MCA now known as MHRA Quality management
(www.mca.gov.uk)
of GMP GMP as per TGA system
Integrate quality in all
(www.tga.gov.au) Vendor Qualification
works / areas
Follow the written GMP as per US FDA
procedure (www.fda.gov)
GMP as per ICH guidelines Risk Assessment Audit for Compliance Batch Release
(www.ich.org)
Write Procedures Be clean Maintain Data Integrity

Personnel must aware

Organization Chart
Area restricted to authorized GMP/GLP
personnel

Reconciliation of the In-process controls & Regular trainings & Its

Sufficient Qualified Personnel
product Environmental controls effectiveness check

cGMP
Clearly defined
Performed & supervised by Production Personnel responsibilities
competent people

Personnel Hygiene
Unidirectional Flow
Medical Examination prior to
Avoid mix up & cross recruitment Use protective
contamination garments

Validation of Critical
Yields should be monitored &
steps
should be within limit

Quality Control
Maintained as per requirement
Document Traceability Laboratory reagents, Volumetric
Procedure for all
activities solutions, reference standards and
Culture media- as per procedure Regular monitoring of Environmental
Adequate Size
conditions
System to retrieve superseded
documents Approved, signed and dated by Testing of all Materials as per Validated & Approved Analytical
authorized procedure Methods Sufficient place for
warehousing
Qualification &
Only current version to Calibration
be in used Mfg / Testing records, Log Premises &
Documentation books, Line clearance records,
Flow in logical order
protocol & reports etc. Equipment
Online documentation for all Properly labelled & Store as per
activities requirements
Unambiguous contents
Pipe work with flow
directions Separate room for sensitive
Electronically stored-Protected Reproduced documents-clear Instruments/ Materials
by backup support and legible
Contact parts must not be reactive,
additive or absorptive Easy to Clean

A good GMP document should be Accurate, Clear, Complete, Consistent, Indelible, Legible, Timely, Direct, Authentic and Authorized.