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Good Manufacturing Practice Audit checklist

Documentation and Records

Adequate and up-to-date documentation of manufacturing procedures and instructions

Properly maintained and organized records of raw materials, equipment, and personnel

Effective change control procedures in place for modifications to manufacturing processes

Facility and Equipment

Clean and well-maintained production areas, storage areas, and equipment

Proper segregation and labeling of different materials to prevent cross-contamination

Regular calibration and maintenance of equipment to ensure accuracy and reliability

Personnel

Sufficiently trained and qualified personnel responsible for manufacturing operations

Adequate protective clothing and hygiene practices followed by all staff

Clear procedures for reporting and addressing deviations or non-conformities

Material Management

Proper storage and handling of raw materials, intermediates, and finished products

Accurate identification and labeling of all materials to prevent mix-ups or misidentification

Regular monitoring and control of material expiry dates and shelf-life

Production Process

Clearly defined and documented manufacturing processes, including critical control points

Adherence to approved batch records and standard operating procedures

Effective monitoring and control of in-process controls and critical process parameters

Packaging and Labeling

Verification of correct packaging materials and their compliance with regulations

Proper labeling of products with accurate information, including batch numbers and expiry dates

Adequate controls to prevent mix-ups or mislabeling during packaging operations

Quality Control and Testing

Well-established quality control procedures and testing protocols

Regular calibration and verification of testing equipment and instruments

Proper handling and storage of retained samples for future reference or retesting

Distribution and Storage

Proper transportation, storage, and handling of finished products to avoid damage or contamination

Adequate temperature and humidity controls during storage and distribution

Effective recall procedures in place to respond promptly to any product quality issues

Documentation and Record-Keeping

Accurate and complete documentation of all manufacturing, testing, and quality control activities

Proper retention and archiving of records according to regulatory requirements

Availability of records for review during inspections or audits

Training and Continuous Improvement

Regular training programs for employees to ensure understanding and compliance with GMP standards

Continuous improvement initiatives to identify and address areas for enhancement in manufacturing processes

Regular internal audits and management reviews to monitor and improve GMP compliance

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