Quality Assuarance For Pharmaceutical Products

Quality Assurance

Quality Assurance of the pharmaceuticals, biopharmaceuticals, medical devices and active pharmaceutical ingredients(APIs) includes the specification and the control of their raw materials. While manufacturing a pharma drug. Controlling the quality of raw materials (RMs) used is as important as controlling the quality of your APIs and your finished product. An RM qualification and control program are considered as the key factor in assuring the quality of medicinal drugs, yet it is often deemed as secondary importance at a busy firm.

A GMP(Good Manufacturing Practice) and regulations require that pharmaceutical raw materials and the suppliers be qualified both initially and periodically. It is wise to initiate a quality system which will ensure that your finished product meets its quality attributes. Patient safety is the key reason for this requirement. Legally, a pharmaceutical firm takes on full responsibility for the quality of the raw materials it purchases and uses in the manufacturing process. Consequently, it is in the business interest of the firm to exercise quality suppliers and test laboratories and to categorize RMs appropriately.

A raw material qualification should be carefully defined in GMP procedures and placed under strict charge control. The critical status of an RM is related directly to its intended use in the process and the potential risk created by a quality deficit in the RM that may affect the product's identity, efficacy or purity.

Selecting the right raw material for pharmaceutical drugs Key considerations while choosing the raw materials include : Is there enough material to support the safety of the material selected? Is this raw material used in regulating industry? Is it known to have toxicological concerns Is the supply of this material limited? If so, can it be replaced by another? If not, it is critical to ensure the supply of this material so that no shortage occurs.

Ensuring the right quality of raw material Once the product design is finalized, implement a supplier management program to assure and control the quality of raw ingredients. Some of them are : Accessing the quality of raw materials through testing. Performing supplier audit. Considering information obtained via ongoing communication with suppliers

Basic concerns about the supply of quality raw materials

A firm faced the practical challenge of establishing and operating an efficient system that assures a supply of quality raw materials that are tested and then released for manufacturing. A properly functional warehouse makes sure that the unpredictable RM problems can be resolved with the delay in manufacturing.

Business Needs: First, determine your internal business requirements. A development organization will usually need a flexible raw material qualification process that can quickly assess up to 100 more new materials and suppliers. Furthermore, their changes are expected during development.

Stepwise Process : Process thinking is especially helpful in setting up the system for raw materials and supplier qualification. Here are some points that must be part of a RM qualification process : Step 1 : Collect information regarding the raw material : What grades are available, and what does the suppliers test for? Is this RM critical or non critical based on its use.

Step 2 : Determine the qualification strategy and set your acceptance criteria for this RM: The quality profile includes those biochemical. Chemical, or microbiological characteristics consistently possessed by the raw materials and the process Step 3 : Analyze the test results and information derived from supplier evaluations : Determine the nature of information got from each test. Some obvious ones would be purity, activity and identity. Others, such as impurities, moisture may be less directly related to your immediate use of material. Based on the data obtained during qualification, approve the final selection of raw materials. Many Indian as well as universal raw material suppliers like Tatva Chintan Pharma Chem, Seek and Source and Sparchem are tested positive for providing the qualified products for pharmaceutical companies.

Controlling the quality of raw materials used during manufacturing by qualifying the raw materials and their suppliers help ensure that a firm's final product is well-defined, consistent and suitable for its intended use. Sometimes just changing the supplier of an ingredient may be enough to affect quality of materials. Hence, these materials can affect the quality, safety and efficacy of your product; hence the need for tighter controls.

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