Schedule M

Schedule M is a part of Drug and Cosmetic act 1940. It is GMP for pharmaceuticals that should be followed by pharmaceutical manufacturing units in India.

Schedule M is having the details about company premises, quality control system, quality control laboratories, GMP in production, cleaning of equipments, housekeeping, cross-contamination and other related topics.

Part I: Good Manufacturing Practices for Premises and Materials
Part II: Requirements of Plant and Equipment
PART-I: Good Manufacturing Practices for Premises and Materials
A. General Requirements
B. Warehouse
C. Production Area (New concept)
D. Ancillary area (New concept)
E. Quality Control Area (New concept)
F. Personnel (new concept)
G. Health, clothing & sanitation of workers
H. Manufacturing Operations & Controls
I. Sanitation in the manufacturing Premises
J. Raw Material
K. Equipment
L. Documentation & Records (New concept)
M. Labels & other Printed Materials
N. Quality Assurance (New concept)
O. Self inspection & internal Quality Audit (New concept)
P. Quality Control System
Q. Specifications (New concept)
R. Master Formula Records
S. Batch Processing Record
T. Packaging Record (New concept)
U. Batch Packaging Record
V. SOPs (New concept)
W. Reference Sample (New concept)
X. Reprocessing & Recovery
Y. Distribution Record
Z. Validation & Process Validation ( New concept)
AA. Product Recall (New concept)
AB. Market Complaints & Adverse Reaction
AC. Site Master File (New concept)

PART-IA: Requirements For Manufacture Of Parenteral & Ophthalmic Preparations
PART-IB: Requirement For Manufacturing Of Oral Solid Dosage Forms (Tablets & Capsules)
PART-IC: Specific Requirements For Manufacture Of Oral Liquids
PART-ID: Specific Requirements for Manufacture of External Preparations:
PART-II Requirements of Plant and Equipment
Click here to Read Full Schedule M