This document provides definitions and requirements for cGMP (Current Good Manufacturing Practice) and GDocP (Good Documentation Practice). It outlines general hygiene and documentation requirements for employees, including wearing clean uniforms, undergoing training, and avoiding practices like carrying documents in pockets. Specific requirements are described for areas like stores/weighing, production, and packaging. Guidelines are provided for paper documentation including completely filled records, traceability, error corrections, and understanding related SOPs. Common human errors are also acknowledged.

1. cGMP &GDocP
Standard Operating Procedures

2. Training on QAS-113
1. QAS-113: Current Good Manufacturing and
Documentation practices in the premises
2.Questionnaires
| 2

3. Definitions & Abbreviations
 cGMP
Current good manufacturing practice-The act of current up to date
methodologies, practices and procedures which are to be followed
in the testing and manufacturing of pharmaceuticals.
 GDocP
Good documentation practice –the measures that collectively and individually ensure
documentation, whether paper or electronic is secure, attributable, legible, traceable,
permanent, contemporaneously recorded, original and accurate.
 ALCOA
An acronym stands for the fundamental elements of data integrity (attributable-legible-
contemporaneous-original and accurate)

4. General requirements
• Employees should wear clean uniforms and ensure protection of the
product
• All manufacturing operations shall be carried out in dedicated area
intended for defined purpose
• Insecticutors should be available on entrance of all plants
• All records must be completed at the time of action
• Employees shall be qualified and should undergo training before
commencing their work.
• Hygiene practices are mandatory

5. Avoided practices (Don’ts)
• Do not enter plant if suffering from contagious disease
• Do not keep medicines inside locker except prescribed for personal
use.
• Do not carry batch record and support documents in your pockets and
lockers
• Do not use tools dedicated for JIII, JIV & JIX for other plants to prevent
cross-contamination.

6. Additional requirements
• Requirements for stores & weighing area
Example: temperature, humidity and pressure should be maintained.
• GMP in production area
Example: MFM & batch related formats should be completed in “concurrent”
or as close as possible to the event occurring when performing a task.
• Requirement for sterile products facilities
Example: Aseptic techniques should be followed to avoid contamination
• Packaging operations requirements
Example: all printed packaging material are kept under lock and key

7. GDocP
• All paper records should be filled completely, traceability and durability of
records should be maintained
• Post sticks should no be used in GMP documents
• Lot numbers and ID codes should be double checked.
• Proper date formats should be used (dd mm YYYY), 24 hour format
• Errors should be corrected with one straight line through the original
entry, initial, dates and explained if necessary.
• All employees should understand and follow SOP related to their work
• Name should be included in document design
• Signature can be arranged on pages to provide authenticity

8. Human Errors

9. 9
Thank you !