Last Updated on December 21, 2024 by The Health Master

Personnel

Key considerations for Point No. 11 – Personnel compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Point No. 10 – Self Inspection

Principle

• Establish and maintain a robust Quality Assurance (QA) system.
• Ensure correct manufacturing and control of pharmaceutical products and active ingredients.
• Employ sufficient qualified personnel to fulfill all manufacturing responsibilities.
• Clearly define and communicate individual responsibilities in written descriptions.

General

Personnel Qualifications and Responsibilities:

• Employ adequate personnel with necessary qualifications and experience.
• Distribute responsibilities to avoid risks to quality.
• Document responsibilities of key staff in writing.
• Delegate duties to qualified deputies with clear accountability.
• Ensure no gaps or overlaps in personnel responsibilities.
• Maintain an organizational chart.

Training:

• Provide initial and ongoing training on GMP principles and hygiene.
• Motivate personnel to uphold high-quality standards.

Access Control:

• Prevent unauthorized access to production, storage, and QC areas.
• Restrict non-essential personnel from using these areas as passageways.

Key Personnel

Qualifications and Experience:

• Key personnel (production, quality unit heads, authorized person) must possess relevant qualifications and experience.
• Educational background should include chemistry, chemical engineering, microbiology, pharmaceutical sciences, pharmacology, toxicology, physiology, or related sciences.
• Practical experience in manufacturing and QA of pharmaceutical products is essential.
• Key personnel should be able to exercise independent professional judgment.

Shared Responsibilities:

• Production and quality unit heads share responsibilities for:
• Authorizing documentation
• Monitoring manufacturing environment and plant hygiene
• Validating processes and calibrating equipment
• Training personnel
• Approving and monitoring suppliers and contract manufacturers
• Approving and monitoring storage conditions
• Performing and evaluating in-process controls
• Retaining records
• Monitoring GMP compliance
• Inspection, investigation, and sampling to ensure product quality

Production Head Responsibilities:

• Ensure product production and storage align with documentation.
• Approve production instructions and in-process controls.
• Evaluate and sign production records.
• Oversee maintenance of department, premises, and equipment.
• Ensure process validations and equipment calibrations are performed and recorded.
• Provide initial and ongoing training to production personnel.

Quality Unit Head Responsibilities:

Authorized Person Responsibilities:

• Ensure compliance with technical and regulatory requirements for finished product quality.
• Approve release of finished products for sale or supply.
• Assess finished products based on production conditions, in-process testing, manufacturing documentation, compliance with specifications, and finished pack examination.
• Certify batch release before sale or supply.
• Verify compliance with licensing, GMP principles, process validation, testing, planned changes, additional checks, documentation, audits, quality control approval, and relevant factors.

Training

Training Program:

• Implement a written training program for all personnel involved in manufacturing, control laboratories, technical, maintenance, cleaning, and other relevant areas.
• Provide initial and ongoing training on GMP theory and practice, as well as specific job duties.
• Assess the effectiveness of training programs.
• Maintain training records.

Specialized Training:

• Provide specific training for personnel working in contamination-prone areas (clean areas, hazardous materials handling).
• Emphasize the importance of quality assurance and its implementation during training.

Visitor and Contractor Training:

• Limit visitor access to production and QC areas.
• Provide necessary information and supervision for visitors.
• Ensure consultants and contract staff are qualified and their training is documented.

Personal Hygiene

Health Checkups:

• Conduct regular health checkups for all personnel.
• Provide periodic eye checkups for personnel involved in visual inspections.

Hygiene Practices:

• Train personnel in personal hygiene practices.
• Enforce handwashing and sanitization before entering production areas.
• Restrict personnel with illness or open lesions from handling materials or products.
• Encourage reporting of potential quality issues.

Product Protection:

• Minimize direct hand contact with materials and products.
• Wear appropriate clean body coverings and hair coverings.
• Store used clothing properly.

Environmental Controls:

• Prohibit smoking, eating, drinking, chewing, and storage of food, drink, smoking materials, and personal medicines in production, laboratory, and storage areas.
• Enforce personal hygiene procedures for all personnel, including visitors and contractors.

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Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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Next: Key Notes on Revised Schedule M: Point No. 12 – Premises ….coming soon

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