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Good Documentation Practices (GDP):
• Entries in ink, legible, dated, and signed.
• No overwriting; corrections signed and justified.
• Batch records retained for at least one year after expiry date.
Auditing and Inspection:
• Internal audits ensure compliance with GMP.
• Regulatory inspections by authorities.
• Corrective actions documented and verified.
Importance of Validation Master Plan (VMP):
Comprehensive document describing company’s validation policy, scope, responsibilities, and
schedule.
Product Complaints and Recall:
• All complaints documented and investigated.
• Recall procedure must ensure retrieval of affected batches within 24 hours.
Case Study Example:
A batch of coated tablets showed delayed dissolution. Investigation found over-drying during
coating → reduced polymer permeability. Corrective action: optimize inlet air temperature.
Tablet and Capsule Production – Documentation Flow:
1. Material Receipt:
o Raw materials received and quarantined.
o Identification testing by QC.
o Material released by QA.
2. Dispensing:
o Weighing of ingredients as per master formula record (MFR).
o Performed in controlled environment to prevent cross-contamination.
3. Manufacturing:
o Mixing → Granulation → Drying → Milling → Lubrication → Compression.
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