In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
In-process quality control may be performed at regular intervals during a process step (e.g. tableting or encapsulation) or at the end of a process step (e.g. granulation, blending). The tests allow the formulation scientist to identify and follow all changes that may occur during applied technological procedures. It gives the formulation scientist security that the finished products fulfil all quality requirements, most of all that all the products should be safe for the patients.
All the in-process controls including those made in the production area by production personnel should be performed according to methods approved by quality control department (EU-GMP guide). Usually, tests are carried out by production personnel, especially for convenience. The personnel in the production area do not have to be directly responsible to the production manager or head with disciplinary responsibility.
On the basis of organizational instruction and process description, quality control personnel may carry out the necessary tasks, if carried out by the production personnel the head must make sure that the controls are used as a means of controlling process in accordance with the instructions and the results taken into account. The responsibility and tasks for the in-process control must be clearly laid down in the organizational instruction. When deviation occurs or where release analyses of intermediate are carried out outside production area, a method must be defined that prevent continued processing of the materials until the decision or the result is available. Materials may be rejected by means of operating data. Physical designation of the product by means of labelling is recommended.
In-process control may be carried out within production area provided they do not jeopardize production. It means that care must be taken when sampling or testing. Examples of in-process tests influence on production are the influence of disintegration test on room humidity and the risk of microbial contamination posed by leak test on blisters. Tests are normally carried out in a segregated area and not directly at the manufacturing location.
Uniform sampling is carried out throughout the entire batch production. A sampling plan includes the process and location for sampling, the number of samples and other information such as:
Samples are tested to verify conformance with specifications such as identity, components conformity to written specifications, container/closure conformity with written specifications and examination for contamination. The tests to be performed and the methods to be used have to be defined and specifications also established. Also, use of certificates of analysis or certificates of conformance has to be established.
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Any necessary in-process controls and environmental controls carried out must be recorded. This documentation record must include a record of the in-process controls, the initials of the person(s) carrying them out, and the results obtained. In case of deviation, the signature of the person who approved the deviation is required. Each deviation from the specifications must be countersigned by a qualified person. Also, reasons for deviation, measures including the justification for deviation, date, and name of the person authorizing it must be documented. The head of production is responsible for deviation procedure.
In addition to the numerical compilation of data, a graphical representation of process control values is recommended. This provides simplified overview that makes it possible for trends to be easily detected at early stage.
The quality of pharmaceutical dosage forms is essential to assure the maximum level of patient’s satisfaction. To safeguard quality, pharmaceutical companies should possess an organization which enables a proper system of quality assurance of pharmaceutical products and active ingredients. They should able to define in quantifiable terms the quality of raw materials used in the production processes and the quality of products/ drugs they manufacture. This will enhance a safe and healthier society.
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