RAW MATERIAL TESTING
Raw material testing is crucially important for ensuring safety, quality and efficacy of pharmaceutical products. There are many things to be considered that could impact the way raw materials need to be blended, such as polymorphism, the particle size of raw materials and other properties.
Hence, raw material analysis is essential to determine the purity, identity and quality of the raw materials before they go into the manufacturing process.
WHAT IS RAW MATERIAL TESTING ?
Before finished pharmaceutical dosage forms are produced, the identity, purity, and quality of raw materials must be established with the use of suitable test methods. Raw materials testing through HPLC machines ensures that the raw materials used in pharmaceutical products are suitable for their intended use. Conducting raw materials analysis using appropriate test methods and successfully meeting the challenges of such testing can prevent costly production problems and delays.
Manufacturers take various approaches to raw materials testing compliance. Some get it qualified by performing an initial detailed vendor audit followed by an annual qualification consisting of full pharmacopeial monograph testing on the lots of material. If the qualification lots test successfully, then subsequent material shipments will require only monograph identification testing. However, companies that take a more conservative approach to raw materials release as they require full monograph testing for each lot of supplied material.
WHAT IS RAW MATERIAL TESTING IN AYURVEDA ?
- Concept of Ayurveda is very clear that there is nothing in this nature which cannot be used as medicine, as every thing in cosmos is created out of the conglomeration of five elements ie. either, air, fire, water and earth including the body. Accordingly medicines are derived from almost all natural sources of raw materials like plants, minerals, metals and marine products after their suitable processing for efficacy, safety and palatability.
QUALITY ASSURANCE
From a quality assurance standpoint, three critical factors should be considered when assessing a raw materials laboratory: instrument validation/qualification, deviation management, and out-of-specification (OOS) procedures. The diversity of instrumentation used by raw materials, laboratories place a heavy burden on validation efforts. Instrument vendors often provide installation qualification (IQ), operational qualification (OQ), user training, and after-purchase support, but a large portion of the validation efforts falls on the laboratory, especially with regard to computerized systems. Therefore, the laboratory must define instrument function requirements to outline operational needs and compliance requirements and provide criteria against which the instrument is validated.
To provide evidence that the entire system (i.e., hardware, software, associated instrumentation or components) meets user-defined functional requirements and specifications and that performance meets predetermined levels of accuracy, reliability, and data integrity, performance qualification (PQ) must be conducted using test cases that represent and challenge the production environment. For instrumentation to remain in a validated and controlled state, changes and enhancements must be performed under a formalized change-control system.
Although the challenges associated with raw materials testing are extensive, manufacturers can prevent costly production problems and delays by confirming early in the production process that the raw materials in their products are suitable for their intended use.