Quality Management Documentation

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