Fundamentals of Quality Control Practice in Pharmaceuticals

QC testing is only designed to test for product attributes that are well-known and understood. These attributes are part of the product specification. However, laboratory testing cannot pick up all the defects the test may not exist, the test may not be sensitive enough, or the test may not be required for that product. Companies therefore have to rely upon GMP rules and QA systems to prevent these problems from occurring in the first place. 

General Requirement 

The establishment of any specifications, standard, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specification, standard, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate unit and reviewed and approved by the quality control unit.

Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. 

GMP Manufacturing Facility

International GMPs

Quality control is that part of GMP Manufacturing Facility which is concerned with sampling, specifications, and testing and with the organization, documentation, and release procedures which ensure that the necessary and relevant tests are carried out and materials are not released for use, nor products released for the sale or supply, until their quality has been judged to be satisfactory. 

Quality control is the part of QA that checks the quality of a batch after it has been manufactured. QC verifies that ingredients and products meet written and approved standards, often called “specifications”.

The role of the QC laboratory then is to detect any possible defects once they have occurred, rather than prevent them from occurring in the first GMP rules place the QC laboratory-specific responsibilities include:

• Sampling, inspecting, and testing of starting material and finished product. 
• Calculating and checking results against specifications.
• Reporting all the results and releasing on-passed batches. 

Typical sample flow in a QC laboratory

Received labeled sample 

The laboratory maintains a Sample receiving register. The register logs the botch and sample number, number of samples provided and the lime and date the sample first entered the laboratory. This is the commencement of the sample tracking. 

Prepare samples and set up

Many test methods require preparation before the test is run. The test method should describe exactly how the sample is prepared. This may involve simple dilution or more complex extraction and manipulation. Always refer to the current test method before setting up the sample. 

Verifying system suitability 

For instrumental runs such as HPLC/GC, the test method usually a verification that the entire instrumental system is performing satisfactorily on the day of the run. This is called “system suitability testing” (SST). Non-instrumental methods may also include control or equivalent verification systems. The test methods should describe how the integrity of particular test runs is verified. 

Calculate/check results

Once the sample has been run, either the instrumental or the analyst will perform a calculation to arrive at a result. It is essential to double-check all the calculations before finalizing sample results. 

Excipact Certified

Final words

Quality is everyone’s job, and it should pervade every aspect of pharmaceutical manufacture Excipact certified packaging. Quality should not be tested into products; rather, it must be built in at each step of manufacture. Quality manifests itself in not obvious ways, such as during actual processing steps, but also diverse areas such as vendor assurance, personnel training, internal audits, change management, release for the supply, and QC sampling.