During the WHO GMP inspection of AABBCC Pharmaceutical Plant, the inspection team observed that independent verification of weighing activities was not consistently performed and/or documented during dispensing of raw materials. The observation indicated deficiencies in the implementation of the weighing verification process, despite the availability of approved Standard Operating Procedures (SOPs) governing dispensing and weighing operations.

WHO GMP requires that weighing and dispensing of raw materials be independently verified to ensure that the correct material and quantity are dispensed according to the approved Batch Manufacturing Record (BMR) or dispensing order. The absence of documented independent verification increases the potential risk of incorrect weighing, material mix-up, incorrect potency, batch failure, and regulatory non-compliance.

Immediately following the observation, Quality Assurance initiated an investigation. A comprehensive review of weighing records, dispensing logs, Batch Manufacturing Records (BMRs), equipment logbooks, calibration records, personnel training records, and recent manufacturing batches was conducted.

The retrospective review confirmed that although weighing verification was not consistently documented, there was no confirmed evidence that incorrect quantities of raw materials had been used in released commercial batches, as reconciliation records, analytical testing, in-process controls, finished product testing, and batch release documentation remained compliant. Nevertheless, the lack of documented weighing verification represents a significant weakness in GMP documentation and procedural compliance requiring comprehensive corrective and preventive actions.

2. ROOT CAUSE ANALYSIS (DETAILED)

A multidisciplinary investigation team comprising representatives from QA, Production, Warehouse, QC, and Engineering performed a systematic investigation using the 6M (Man, Machine, Method, Material, Measurement, Management) methodology.

A. Man (Personnel)

• Personnel occasionally relied on experience rather than following the documented independent verification process.
• Independent verifier signatures were omitted in certain records due to inadequate attention to documentation requirements.
• Refresher training on weighing verification and Good Documentation Practices (GDP) was not conducted at the desired frequency.
• Supervisory monitoring during dispensing activities was insufficient.

B. Method (Procedure)

• Existing SOP described weighing verification but did not clearly define:
  • Verification sequence.
  • Responsibilities of primary operator and verifier.
  • Actions to be taken if discrepancies are identified.
  • Documentation requirements for electronic and manual records.
• Verification checklist was not available as a controlled document.
• No mandatory QA verification for critical APIs.