Quality Management Documentation

Study Notes

Documentation Principles

Good documentation is essential for Quality Assurance (QA) and Good Manufacturing Practices (GMP)
Clear documentation prevents errors from spoken communication
Specifications, formulas, manufacture, instructions, procedures, and records should be free from errors and available in clear written form

Specifications

Describe all details for materials requirements and product features
Serve as a basis for Quality Assurance (QA)

Manufacturing, Processing, and Formula

Clear instructions for all operations
Include manufacturing, processing, formula, and packaging information

Procedures

Clear directions for all operations
Include cleaning, sampling, testing, environmental control, etc.

Records

Include batch production records (BPR), batch manufacturing records (BMR), and final product details
Also include distribution records

Specifications of Documents

Should be signed, approved, dated by authorized person
Should have a clear title, contents, nature, and purpose
Should have regular revisions
Any alterations should be approved, signed, and dated by authorized person
Reasons for alteration and clear details should be provided
Completed step by step after each activity
Kept at least for 1 year after expiry of batch

Types of Documents

Specifications for intermediate and bulk products
Specifications for finished products, including: • Product name, reference code • Formula of the product, pharmaceutical dosage form • Approved supplier • Shelf life • Procedures for sampling, testing • Qualitative & quantitative accepted limits • Storage period and special handling procedures

Processing Instructions

Include: • Processing location and used equipment • Method, reference, critical equipment (cleaning, sterilization) • Detailed stepwise instructions • In-process control instructions • Accepted final yield, and limits • Any precautions or observations

Packaging Instructions

Authorize instruction for packaging for each product
Include: • Package size and type in terms of numbers, weights, volumes • Name of the product • Pharmaceutical dosage form, strength • Clear printed shelf life and batch reference number • Description for packaging operation and used equipment • In-process control, sampling, accepted limits

Batch Product/Packaging Record (BPR)

For each product, each batch, carry BM number
Check for required and unrequired procedures, documents, equipment, materials
Include: • Name of the product • Date and time of production • Personnel responsible for production and in-process control • Description for batch quantities in weight or package number • Notes for special problems

Standard Operating Procedures (SOPs)

Detailed written procedures for performing a particular operation correctly
Typically includes: • General system description • Operation instruction • Responsibilities for system users and administration • Performance verification requirement • Description for batch quantities in weight or package number • Accepted criteria • Frequency of testing • Correction decision for instruments not meeting required performance • Services, major and minor repair, parts replacement

Description

This quiz covers the principles and importance of good documentation in quality management and Good Manufacturing Practice (GMP). It highlights the role of documentation in preventing errors and ensuring clear communication.