Schedule-T

Good Manufacturing Practices

for ASU Medicines [Draft ]
by – Ravindra Prakash
 Schedule - T
• Part – I
– Primary Information
– Information covered in 28 Sections
• Part – II
– Supplements
– 4 No. of Supplements
 Sections
1. GENERAL REQUIREMENT
2. WAREHOUSING AREA
3. PRODUCTION AREA
4. ANCILLARY AREA
5. QUALITY CONTROL AREA
6. PERSONNEL
7. HEALTH, CLOTHING AND SANITATION OF WORKERS
8. MANUFACTURING OPERATIONS & CONTROLS
9. SANITATION IN MANUFACTURING PREMISES
10. EQUIPMENTS
 Sections
11. DOCUMENTATION AND RECORDS
12. LABELS AND OTHER PRINTED MATERIALS
13. QUALITY ASSURANCES
14. SELF INSPECTION & QUALITY AUDIT
15. QUALITY CONTROL SYSTEM
16. SPECIFICATIONS
17. MASTER FORMULA RECORD
18. PACKAGING RECORDS
19. BATCH PACKAGING
20. BATCH PROCESSING RECORDS
 Sections
21. STANDARD OPERATING PROCEDURES (SOPS)
22. REFERENCE SAMPLES
23. REPROCESSING & RECOVERIES
24. DISTRIBUTION RECORDS
25. VALIDATION AND PROCESS VALIDATION
26. PRODUCT RECALLS
27. COMPLAINT AND ADVERSE REACTION
28. SITE MASTER FILES
 Part-II
A. List of Machineries, Min. Area for Mfg. of Ayurveda
& Siddha medicines.
B. List of Machineries, Min. Area for Mfg. of Unani
medicines.
C. List of Equipment for In-House Q.C. Lab
D. Specific Requirement for Mfg. of Rasaushadhis
 New Updates in Draft GMP
• Water System
– Previously ‘Water Supply’, Pure & Potable quality
water.
+ Water from validated system
+ Water should conform to ASU Pharmacopoeial
Specifications
+ Cleaning of Tank & Record maintenance
 New Updates in Draft GMP
• Disposal of Waste
– as per Guidelines of pollution control authorities
+ Disposal of sewage & effluents (Solid, Liquid &
Gas) conform with Env. Pollution control board.
+ Bio-medical waster as per Bio-Medical Waste
Rules 2011
+ Records to be maintained for disposal of rejected
drugs.
+ Storage of Hazardous, Toxic & Inflammable
Materials as per Central & State Legislations.
 New Updates in Draft GMP
• Warehousing Area
– Previously, No separate information
+ Adequate areas for various categories of materials;
also for products in quarantine, released, rejected,
returned or recalled, machine & equipments spare
parts
+ In special storage conditions, Temp./Humidity
+ Separate Sampling Areas
+ Proper Segregation in Storage of Packaging Materials.
+ Poisonous substances in Safe Storage Conditions.
+ Maintain Raw Materials records as per Schedule T-A
 New Updates in Draft GMP
• Production Area
– Previously, No separate information
+ Design to allow uni-flow & logical sequence of
operations.
+ Service lines arranged to avoid – accumulation of
dust, with Color & Direction marking.
+ Adequate space for orderly placement of Equipment
& Material used to facilitate
• Easy & Safe Working
• Minimise or Eliminate any Risk of Mix-up
• Prevent cross contamination
 New Updates in Draft GMP
• Ancillary Area
– Previously, No separate information
+ Rest and Refreshment Rooms separate from
Manufacturing & Storage Areas.
+ Facility for Changing, Storing Clothes & for
Washing / Toilet shall be Easily accessible &
Adequate for no. of users; with Written
Instruction for Cleaning & Disinfection.
+ Maintenance Workshop, Separate & away from
Production Areas.
 New Updates in Draft GMP
• Quality Control Area
– Previously, ‘Quality Control’
+ Independent of Production areas.
+ Separate areas for Pharmacognostical, Chemical &
Microbiological Analysis.
+ Separate instrument room for sensitive & sophisticated
instruments.
+ Sufficient & Suitable storage space for Test samples, Retain
samples, Reference Standards, Reagent & Records.
+ Separate AHU & other requirement for Pharmacognostical,
Chemical & Microbiological Testing Areas.
 New Updates in Draft GMP
• Personnel
– Previously, No separate information
+ Manufacture shall be conducted under the Direct
Supervision of Competent Technical Staff
+ Head of the Quality Control Laboratory shall be
Independent of the Manufacturing unit
+ Written duties of technical and Quality Control
personnel
 New Updates in Draft GMP
• Manufacturing Operations and Controls
– All New Information
+ All manufacturing operations shall be carried out
under supervision of technical staff approved by the
Licensing Authority.
+ Precautions against mix-up and cross-contamination.
+ Prevent mix-up and cross-contamination of drug
material and drug product by proper air-handling
system(AHU), pressure differential segregation.
+ Packaging lines shall be independent and adequately
segregated.
 New Updates in Draft GMP
• Sanitation in Manufacturing Premises
+ Premises shall be cleaned and maintained in an
orderly manner.
+ Validated Cleaning Procedure shall be maintained.
+ Routine Sanitation Program shall be drawn up and
observed.
 New Updates in Draft GMP
• Equipments
+ All New Information
+ Each equipment shall be provided with a Log book,
wherever necessary.
+ Balances & other equipment with appropriate Range &
Accuracy; Calibrated and with SOPs.
+ Parts of production equipment that come into contact with
product shall not be reactive, additive or adsorptive.
+ Wherever possible, Non-toxic/Edible grade lubricants shall
be used.
+ List of equipments and machinery recommended is
indicated in Part II A.
 New Updates in Draft GMP
• Documentation & Records
+ To define the Specifications for all Materials,
Methods of Manufacturing , Control, Personnel,
Release of Batch, Audit Trail.
+ All Information about Standard Documentation
Practices
 New Updates in Draft GMP
• Labels & Other Printed Materials
+ Information about Product Labels.
+ All Containers & Equipments shall bear Labels.
+ Different colour coded labels shall be used to
indicate the status of a product (for example:
under test, approved, passed, rejected).
+ Prior to release, Labels, Cartons and Boxes and all
circulars, inserts and leaflets shall be examined by
QC.
 New Updates in Draft GMP
• Quality Assurance
+ Objectives mentioned.
+ ASU products are designed & developed in a way
that takes account of the requirements of Good
Manufacturing Practices and other associated
codes such as those of Good Laboratory Practice
and Good Clinical Practices Guidelines.
 New Updates in Draft GMP
• Self Inspection & Quality Audit
+ Constitute a Self Inspection Team for Assessment
of all or part of a system with the Specific Purpose
of Improving it.
+ Written instructions for Self-Inspection.
 New Updates in Draft GMP
• Quality Control System
+ Concerned with Sampling, Specifications, Testing,
Documentation, Release procedures.
+ Stability Studies.
+ Procedure to Carry Out Stability
 New Updates in Draft GMP
• Specifications
+ Raw Material & Packaging Materials
+ Content of Specifications
+ For Plastic Containers & Closures.
+ For In-Process & Bulk Products
+ For Finished Products
 New Updates in Draft GMP
• Master Formula Record
+ There shall be MFR for all products.
+ Content of MFR
 New Updates in Draft GMP
• Packaging Records
+ There shall be Authorised Packaging Instruction
for all products.
+ Content of Packaging Records
 New Updates in Draft GMP
• Batch Packaging Records
+ Document with Information of all Packing
Operations used in a Batch.

• Batch Processing Records

+ Document with Information of all Manufacturing
/Processing operations used in a Batch.
+ Content of BPR
 New Updates in Draft GMP
• Standard Operating Procedures (SOPS)
+ Receipt & Sampling of Material
+ Batch Numbering
+ Testing
+ Record of Analysis
+ Equipment Assembly & Validation
+ Analytical Apparatus & Calibration
+ Maintenance, Cleaning & Sanitation.
+ Pest Control
+ Complaints, Recall etc.
 New Updates in Draft GMP
• Reference Samples
+ Each lot of every active ingredients, in a quantity
sufficient to carry out all the tests.
+ Samples of Finished Product shall be stored in the
same or simulated containers.
 New Updates in Draft GMP
• Reprocessing and Recoveries
• Distribution Records
• Validation and Process Validation
• Product Recalls
• Complaint & Adverse Reactions
• Site Master File
+ Detailed information to prepare SMF