Standard Operating Procedure for Good Manufacturing Practices (GMP) Compliance

1) Purpose

This SOP outlines the procedures for ensuring compliance with Good Manufacturing Practices (GMP) to consistently produce pharmaceutical products that meet quality and regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the manufacturing, packaging, labeling, testing, storage, and distribution of pharmaceutical products within the facility.

3) Responsibilities

The Quality Assurance Manager or designated personnel are responsible for overseeing GMP compliance. Production, quality control, and quality assurance personnel are responsible for implementing GMP requirements in their respective areas.

4) Procedure

4.1 Facility and Equipment

1. Maintain facilities and equipment in a clean, orderly, and suitable condition for their intended use.
2. Implement and document preventive maintenance programs for critical equipment.

4.2 Personnel

1. Provide appropriate training to personnel on GMP requirements and procedures relevant to their duties.
2. Ensure personnel adhere to hygiene practices, gowning procedures, and other applicable GMP guidelines.

4.3 Documentation and Record Keeping

1. Maintain accurate and complete documentation of all GMP-related activities, including production records, batch records, and quality control testing results.
2. Ensure records are legible, retrievable, and securely stored in accordance with retention policies.

4.4 Production and Process Controls

1. Implement procedures to control production processes and ensure consistency and uniformity of pharmaceutical products.
2. Verify and validate critical process parameters to ensure product quality and compliance.

4.5 Quality Control and Testing

1. Conduct in-process and finished product testing according to approved specifications and procedures.
2. Ensure testing methods are validated and equipment is calibrated and maintained.

4.6 Storage and Distribution

1. Establish and maintain appropriate storage conditions for pharmaceutical products to prevent contamination, deterioration, or damage.
2. Implement procedures for the proper handling, packaging, labeling, and distribution of finished products.

4.7 Deviations and Corrective Actions

1. Document and investigate deviations from established procedures and specifications.
2. Implement corrective and preventive actions (CAPA) to address root causes and prevent recurrence of deviations.

4.8 Audits and Inspections

1. Conduct internal audits to verify GMP compliance and identify areas for improvement.
2. Prepare for and cooperate with regulatory inspections, providing necessary documentation and facilitating inspections as required.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practices
CAPA: Corrective and Preventive Actions

6) Documents, if any

GMP Compliance Checklist, Training Records, Equipment Maintenance Logs, Batch Production Records, Deviation Investigation Reports, Audit Findings and Corrective Action Plans

7) Reference, if any

Regulatory guidelines such as FDA Current Good Manufacturing Practice (CGMP) Regulations (21 CFR Parts 210 and 211), ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Good Manufacturing Practices for Pharmaceutical Products

8) SOP Version

Version 1.0