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Schedule M

Know about Schedule M in detail including Good Manufacturing Practices for Premises & Materials and Requirements of Plant and Equipment.

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, house keeping, cross contamination and other related topics.

Ø   Part I : Good Manufacturing Practices for Premises and Materials
Ø   Part II: Requirements of Plant and Equipment.
•  PART-I  Good Manufacturing Practices for Premises and Materials
A. General Requirements
B. Ware house
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)
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. SOP (New concept)
W. Reference Sample (New concept)
X. Reprocessing & Recovery
Y. Distribution Record
Z. Validation & Process Validation ( New concept)
AA. Product Recall (New concept)
BB. Complaints & Adverse Reaction
CC. Site Master File (New concept)
Requirements For Manufacture Of Parenteral & Ophthalmic Preparations
Requirement For Manufacturing Of Oral Solid Dosage Forms (Tablets & Capsules)
Specific Requirements For Manufacture Of Oral Liquids
Specific Requirements for Manufacture of External Preparations:

Click the following link to view the Full Schedule M.
 GMP and Requirements of premises, plant and equipment for pharmaceutical products.

Also Read:
Drug & Cosmetic Act 1940
Good Laboratories Practice (GLP) in Pharmaceuticals
GMP Observations in Production
30 common ways to avoid making the most frequent GMP errors
cGMP guidelines for pharmaceutical industries part-1
cGMP guidelines for pharmaceutical industries part-2

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