QC laboratories are considered high-risk areas because they are often the final step verifying the quality of the drug prior to release/shipment.
Therefore, they should follow GMP regulations to demonstrate the quality and integrity of data. Being in compliance is a prerequisite for successful FDA inspection.
Compliance requirements for laboratories can be divided into two categories:
1. General quality system requirements that apply to all regulated activities within a firm
2. Laboratory-specific technical requirements that apply to specific situations in a laboratory
The overall impact of regulations on a pharmaceutical laboratory can be best illustrated by looking at the whole sample/data workflow (Figure 1).
The upper part of the figure shows a typical laboratory workflow of samples and test data, together with key requirements underneath.
The middle part shows GMP compliance requirements that are applicable to the entire sample or data workflow. The lower part shows general quality assurance requirements that are applicable not only to regulated laboratories but also to other departments within a firm.
All the individual workflow steps as shown in Figure 1 have specific requirements. These include:
- Sampling
- Sample Handling
- Testing
- Test Results
- Record Management
All records associated with testing should be archived. Such records includes:
- Certificates of analysis (COA),
- Instrument and method parameters,
- Supporting information such as chromatograms and spectra, and equipment qualification records.
The archiving period can range from 6 to 15 years, and even beyond. Controls should be in place to ensure security, integrity, and availability of the records during the entire archiving period. Special attention should be paid to electronic records. They should have the ALCOA attributes; Attributable (who generated them), Legible (are they readable), Contemporaneous (are they recorded in real-time), Original (are you sure they have not been changed), Accurate.
Some compliance requirements are applicable for all workflow steps. These are listed in the middle section of Figure 1, and include:
- Validation of analytical methods and procedures
- Equipmentcalibration and qualification
- Equipment maintenance
- Controlled environmental conditions
Pharmaceutical laboratories are expected to follow quality assurance regulations. These include:
- Documentation control
- Organizational structure and responsibilities (Tasks and responsibilities should be defined for each job)
- Qualification of personnel (The effectiveness of trainings should be verified and documented)
- Facilities and environments
- Internal audits
