Page 3 - Documentation and Records

GMP Training – Documentation and Records by www.gmpsop.com

US FDA CFR 211

§ 211.186 Master production and control records.

To assure uniformity from batch to batch, master production and control records
for each drug product, including each batch size thereof, shall be prepared,
dated, and signed... The preparation of master production and control records
shall be described in a written procedure and such written procedure shall be
followed.

(b)Master production and control records shall include:
(9) Complete manufacturing and control instructions, sampling and testing
procedures, specifications, special notations, and precautions to be followed.

International GMPs

Sec 4.15 (extract)
The Processing Instructions should include:
a. a statement of the processing location and the principal equipment to be
used;

b. the methods, or reference to the methods, to be used for preparing the critical
equipment (e.g. cleaning, assembling, calibrating, sterilizing);
c. detailed stepwise processing instructions (e.g. checks on materials, pre-
treatments, sequence for adding materials, mixing times, temperatures);
d. the instructions for any in-process controls with their limits;
…

The need for documentation

GMP regulations require that manufacturers comply with some very important
manufacturing principles. One of these principles addresses the need for
documentation and traceability.

Regulations require manufacturers to keep many records, including records for:

Raw materials

Packaging materials

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