Pharmaceutical Analysis 2: Laboratory Notes -1
PIC/S Guidelines – Chapter 4 – Documentation
Learning Objectives:
1. To demonstrate understanding of the PICS guidelines for documentation.
2. To examine the Good Documentation Practices and required quality control documents.
TOPIC OUTLINE:
Documentation
General Requirements
Specific Requirements for Quality Control Operation
Overview
-The topics will demonstrate understanding of PIC/S guidelines for documentation, related to
Quality Control operation. Good documentation is an essential part of the quality assurance
system and in compliance of GMP requirements.
DOCUMENTATION
General Requirements
-Documentation may exist in a variety of forms, including paper-based, electronic or
photographic media. The main objective of the system of documentation utilised must be to
establish, control, monitor and record all activities which directly or indirectly impact on all
aspects of the quality of medicinal products.
-There are two primary types of documentation used to manage and record GMP compliance:
instructions (directions, requirements) and records/reports.
-Suitable controls should be implemented to ensure the accuracy, integrity, availability and
legibility of documents. Instruction documents should be free from errors and available in
writing.
-Documents should be designed, prepared, reviewed, and distributed with care.
-Documents containing instructions should be approved, signed and dated by appropriate and
authorized persons. The effective date should be defined.
-Standard Operating Procedures, Work Instructions and Methods should be written in an
imperative mandatory style.
-Should be regularly reviewed and kept up-to-date. When a document has been revised, systems
should be operated to prevent inadvertent use of superseded documents.
-Documents should not be hand-written; although, where documents require the entry of data,
sufficient space should be provided for such entries.
-SOP uses clear and direct language and uses active verbs.
- Documents shall:
obe prepared & designed carefully for easy, correct & effective use
ohave the following information:
Company name
