Water is commodiously used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents. Types of Water: Raw Water: Raw water is a natural water available in the environment, such as rainwater, ground water, and water from bodies like lakes … Read more
What is Blister Pack? Blister packaging involves forming a heat softened plastic film into a deep drawn pocket moulds to form a tray (thermoforming), filling with a solid dosage form product and sealing with a push through or peel able covering. Appropriate heat and pressure must be applied to ensure that permanent sealing will be … Read more
Packaging is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use. Importance of packaging: It is important to produce a pharmaceutical product with high quality standards and even it is more important to protect that product form the degradation, external contamination and other physical/chemical … Read more
Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards as defined below. Quality risk assessments begin with a well-defined problem description or risk question. When the risk in question is well defined, an appropriate risk management tool and the types of information needed … Read more
PROCESS VALIDATION Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes … Read more
These are possible approaches to gaining a more systematic, enhanced understanding of the product and process under development. Quality Target Product Profile (QTPP): A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. The … Read more
Foils: Foils are basically acts as primary barrier. Different types of foils are there acts as both base foil and lidding foil. Main role of foil is to protect the drug from Moisture, Light, and Contamination with external environment etc. Examples for different types of foils based on composition.1) PVC foil2) PVC-PVDC foil3) PVC-PE-PVDC foil4) … Read more
The analysis will be carried out in the lab and after analysis if the received material is appropriate (complying with all the specific limits) Material will be released by the QC which means it can be used for the Packing of the Material. For Primary Material: For Secondary & Tertiary Material: Different type of testing … Read more
What is packaging? Packaging is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use. Importance of Packaging To produce a pharmaceutical product with high quality standards and even it is more important to protect that product form the degradation, external contamination and other physical/chemical … Read more
A variation is a change to the dossier of an authorized product. In terms of Marketing Authorizations (MAs) a Variation is: “an amendment to the contents of the documents referred to in Articles 8 to 12 of Directive 2001/83/EC” Once an MA has been granted, the Marketing Authorization Holder (MAH) has a legal obligation to … Read more
