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Compression of Schedule M To Proposed Schedule M: Part I-A

The document summarizes the proposed revisions to Schedule M in India, which provides GMP standards for pharmaceutical manufacturing. The objective is to harmonize quality standards with global regulations. The revisions are aligned with PIC/s standards and aim to help small and medium companies compete internationally using a risk-based approach emphasizing quality risk management principles. The revised Schedule M consolidates requirements into one document organized into 13 parts covering various drug products and manufacturing processes.

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Sangram Kendre
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1K views2 pages

Compression of Schedule M To Proposed Schedule M: Part I-A

The document summarizes the proposed revisions to Schedule M in India, which provides GMP standards for pharmaceutical manufacturing. The objective is to harmonize quality standards with global regulations. The revisions are aligned with PIC/s standards and aim to help small and medium companies compete internationally using a risk-based approach emphasizing quality risk management principles. The revised Schedule M consolidates requirements into one document organized into 13 parts covering various drug products and manufacturing processes.

Uploaded by

Sangram Kendre
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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COMPRESSION OF SCHEDULE M TO PROPOSED SCHEDULE M

The objective behind the revision of Schedule M is the harmonization of quality standards with current global
regulatory requirements.
The harmonization is similar to the requirements of PIC/s standards.
This will help many small and medium companies to compete in export markets, regulated markets.
This new version is designed on a risk-based approach methodology where more emphasis is given to the Quality
Risk Management principles and assessments.

SCHEDULE M
PART 1 GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS
Sr. No. Name of Content Sr. No. Name of Content
1. GENERAL REQUIREMENTS 16. Quality Control System
2. Warehousing Area 17. Specification
3. Production area 18. Master Formula Records
4. Ancillary Areas 19. Packing Records
5. Quality Control Area 20. Batch Packaging Records
6. Personnel. 21. Batch Processing Records
Standard Operating Procedures (SOPs) and
7. Health, clothing and sanitation of workers 22.
Records, regarding
8. Manufacturing Operations and Controls 23. Reference Samples
9. Sanitation in the Manufacturing Premises 24. Reprocessing and Recoveries
10. Raw Materials 25. Distribution records
11. Equipment 26. Validation and process validation
12. Documentation and Records 27. Product Recalls
13. Labels and other Printed Materials. 28. Complaints and Adverse Reactions
14. Quality Assurance 29. Site Master File
15. Self Inspection and Quality audit
PART I-A Specific requirements for manufacture of sterile products, Parenteral preparations (small volume
Injectable and large Volume Parenterals) and sterile ophthalmic preparations.
PART I-B
specific requirements for manufacture of oral solid dosage forms (tablets and capsules)
PART I-C
Specific requirements for manufacture of oral liquids (syrups, elixirs, emulsions and suspensions)
PART I-D specific requirements for manufacture of topical products i.e. external preparations (creams,
ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products)
PART I-E
specific requirements for manufacture of metered-dose-inhalers (MDI)
PART I-F Specific requirements of premises, plant and materials for Manufacture of active pharmaceutical
ingredients (bulk drugs).
PART- II
Requirements of Plant And Equipment
SCHEDUE M-I Requirements of factory premises for manufacture of Homoeopathic
preparations
SCHEDULE M-II
Requirement of factory premises for manufacture of cosmetics
SCHEDULE M-III
Requirements of factory premises for manufacture of Medical devices

Arvind Kumar Srivastava , Mobile No. 9817039581 , Email : [email protected]


REVISED PROPOSED SCHEDULE M

REVISED SCHEDULE M --
Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products
PART I Good Manufacturing Practices for Pharmaceutical Products: Main Principles

Sr. No. Name of Content Sr. No. Name of Content

1. 1. Pharmaceutical Quality System (PQS) 12. 12. Training

2. 2. Quality Risk Management 13. 13. Personal hygiene


3. Good manufacturing practices (GMP) for
3. 14. 14. Premises
pharmaceutical products
4. 4. Sanitation and hygiene 15. 15. Equipment

5. 5. Qualification and validation 16. 16. Materials

6. 6. Complaints 17. 17. Reference Standards

7. 7. Product recalls 18. 18. Waste materials

8. 8. Change control 19. 19. Documentation


9. Production under loan licence or contract and
9. 20. 20. Good practices in production
contract analysis and other activities
10. Self-inspection, quality audits and suppliers’ audits
10. 21. 21. Good practices in quality control
and approval
11. 11. Personnel 22. 22. Computerized systems

Appendix-I Site Master File


Specific Requirements for Manufacture of Sterile Products, Parenteral Preparations (Small Volume Injectable
PART II
and Large Volume Parenterals) and Sterile Ophthalmic Preparations
Specific Requirements for Manufacturing of Pharmaceutical Products Containing Hazardous Substances Such
PART III
as Sex Hormones, Steroids (Anabolic, Androgenic) or Cytotoxic Substances
PART IV Specific Requirements for Manufacture of Biological Products

PART V Specific Requirements for Radiopharmaceutical Products

PART VI Specific Requirements for Phytopharmaceuticals


Specific Requirements for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in
PART VII
Humans
PART VIII Specific Requirements for Manufacture of Oral Solid Dosage Forms (Tablets and Capsules)
PART IX
Specific Requirements for Manufacture of Oral liquids (Syrups, Elixirs, Emulsions and Suspensions)
PART X Specific Requirements for Manufacture of Topical Products i.e. External Preparations (Creams, Ointments,
Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products)
PART XI
Specific Requirements for Manufacture of Metered – Dose Inhalers (MDI)
PART XII
Specific Requirements for Manufacture of Active Pharmaceutical Ingredients
PART XIII
Requirements of Plant and Equipment

Arvind Kumar Srivastava , Mobile No. 9817039581 , Email : [email protected]

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