The Basics of Quality Control in Pharmaceuticals Quality control in pharmaceuticals is a rigorous process designed to ensure the safety, e...
The Basics of Quality Control in Pharmaceuticals
Quality control in pharmaceuticals is a rigorous process designed to ensure the safety, efficacy, and consistency of medications. This process is essential to guarantee that the drugs reaching the end-users are of the highest quality. Here's a detailed look into the fundamentals of quality control in the pharmaceutical industry.
1. Typical Sample Flow in a QC Laboratory
Received Labelled Sample: Every sample entering the QC laboratory is logged in a Sample Receiving Register. This register tracks the batch, sample number, number of samples provided, and the time and date the sample first entered the laboratory.
Prepare Samples and Set Up: Before testing, many methods require sample preparation. This can range from simple dilution to more complex extraction and manipulation.
Run Test Sample: Once prepared, the sample is tested. It's crucial to ensure the sample remains intact and isn't degraded during this process.
Verify System Suitability: For instrumental runs, such as HPLC/GC, there's a verification process to ensure the entire system is functioning correctly on the day of the run. This is known as “system suitability testing” (SST).
Calculate/Check Results: After testing, the results are calculated. It's essential to double-check these calculations before finalizing the results.
2. Out of Specifications (OOS)
All QC laboratories have procedures for handling and investigating results that appear to be out of specification. If an OOS event occurs, it's crucial to notify supervision, retain the sample, and commence a documented investigation.
3. Current Test Method
Before starting any assay, analysts should refer to the current version of the test method. This method should be available at the worksite and should be followed meticulously.
4. Role of the Laboratory in QC Compliance
QC compliance encompasses various activities documented in the GMP rules. These include:
Sampling: Sampling of starting materials and finished products is governed by GMP regulations. All sampling procedures must be documented.
Testing: Testing is mandatory under GMP regulations. However, it's essential to understand that QC testing is more of a defect detection system rather than a QA prevention system.
Reporting Results: The QC lab must maintain various documents, including SOPs, test methods, specifications, registers, logs, and testing records. These documents are of particular interest during GMP audits.
5. Laboratory Documentation
Every product has a specific set of specifications registered with the government authorities. These specifications are crucial as batches may not be released to the market if results do not conform to the approved specifications.
6. Out of Specification (OOS) Conditions
If a single assay result doesn't meet the agreed specification, a laboratory investigation is required. The laboratory must determine whether a laboratory error or a sample/batch failure caused the OOS result.
7. Test Method Validation
The laboratory must validate all test methods to ensure their reliability. This validation verifies various attributes, including precision, accuracy, selectivity, sensitivity, linearity, range, and ruggedness.
8. Sampling
Sampling is the removal of a representative portion of a lot to assess its composition and characteristics. It's essential to understand that no matter how well or how often QC testing is conducted, there's always some risk that defects were not detected in the lot.
9. Corrective and Preventive Action (CAPA) Systems
CAPA systems are crucial for identifying, processing, and resolving issues. These systems ensure that actions are taken to fix problems essential to compliance and improvement.
Conclusion
Quality control in pharmaceuticals is a multifaceted process that ensures the safety and efficacy of medications. By adhering to strict protocols, maintaining thorough documentation, and continuously monitoring and improving processes, the pharmaceutical industry can guarantee the highest quality of products for consumers.
Source: GMP SOP
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