Implementation of GMP in Laboratory Facilities

For the Quality Management System (QMS), conduct a quality assurance program with designated personnel in accordance with GxP regulations. Document the implementation of relevant guidelines in written instructions, including Standard Operating Procedures (SOPs).

Implement Quality Risk Management (QRM) for all quality-related changes to equipment, instruments, and analytical methods. Identify potential risks, assess their impact on quality, and define actions to mitigate risks to an acceptable level, followed by implementing risk control measures.

Ensure that there are sufficient qualified Personnel available to perform GMP analyses. Develop an organization chart that clearly outlines the quality structure of the organization. Establish comprehensive job descriptions and a training matrix, tailored to these job descriptions.

Compile a comprehensive list of major laboratory Equipment, outlining the periodic calibration and qualification of equipment for GMP analytics. Develop and document qualification procedures that include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

For category Validation and Qualification, prepare a comprehensive validation master plan that includes a detailed list of activities, an inventory of equipment and systems, and a catalog of computerized systems. Establish and implement a process for periodic requalification and revalidation. Describe procedures to ensure the ongoing maintenance of qualified and validated status for all systems and equipment.

With regard to Analytical Testing, it is essential to establish written procedures for the collection and documentation of raw data. These procedures should include the verification of accuracy and completeness by a second person. Additionally, outline the procedures for method development, method validation, and the transfer of test methods.

For the Quality Documentation category ensure that comprehensive written procedures are in place for the generation, review, evaluation, and approval of GMP-compliant documents. The Quality Assurance (QA) department is responsible for managing GMP quality documents. Key components include the Site Master File / Quality Handbook, policies and processes, Standard Operating Procedures (SOPs), forms and templates.

For Supplier Management, it is essential to establish written procedures for the identification and selection of potential suppliers. Implement a system to categorize suppliers based on risk assessment criteria. Ensure thorough supplier qualification, including self-questionnaire forms and audits. Create and maintain an up-to-date database of all qualified suppliers. Conduct periodic reviews of qualified suppliers to ensure ongoing compliance and performance.

With regard to Change Control, the following measures are to be implemented:

1. 1. a. Define comprehensive procedures for reporting deviations and changes that affect quality.
   2. b. Develop and enforce processes for evaluating, documenting, and approving deviations and changes.
   3. c. Implement procedures for initiating necessary corrective and preventive actions (CAPA).
   4. d. Establish and maintain a database to track and manage changes.

Establish a risk-based audit plan for Self-inspections and Audits. Begin by defining the audit objectives and identifying the audit team. Specify the areas to be audited and develop a detailed audit agenda. Conduct the audit, then prepare and evaluate the audit report. If necessary, define and implement action items based on the findings.

Define and implement processes for both short-term and long-term Archiving. Evaluate the use of external archiving services and ensure supplier qualification. Identify which GMP-critical documents need to be archived and specify their respective storage durations. Establish comprehensive procedures for the archiving of electronic data.