The records and documents in the pharmaceutical industry are categorized into the following classes:
1. Primary records (contracts, production formulae, packing
instructions, supply source documents, etc.).
2. Procedures or supporting documents (SOPs, instructions,
manuals, guidebooks).
3. Subsidiary records (equipment/instrument printouts,
calibration reading reports, etc.).
4. Quality control records (test methods, test results,
investigations, internal audit reports, Corrective and Preventive Action (CAPA)
reports, recall files, etc.).
Commonly Used Documents
|
Document Name |
Description |
|
Quality Manual |
Describes the
regulations (USFDA/Schedule M/ ICH/ WHO) the company must follow to achieve the
desired level of compliance with cGMP in all operations and products. |
|
Company
policy |
General
description of the company’s outlook on different aspects of the company’s
business and their implementation. |
|
Standard
Operating Procedures (SOPs) |
Stepwise
instructions to perform a given task. |
|
Batch records |
Stepwise
instruction for the production and packaging of drug products. Include
records relating to each batch, and contain entries made during these
processes. |
|
Logbooks |
Bound books
or collections of forms in which operation, maintenance, and calibration
details of equipment are recorded. |
|
Specifications |
List of
requirements that materials and products must meet to be considered
acceptable. |
|
Test methods |
Stepwise
instructions for testing of materials and products. |