Mahummed Asif What exactly is a Blister Pack? Blister packaging is a process that entails shaping a heat-softened plastic film into deep-drawn pocket molds to create a tray (thermoforming), followed by filling it with a solid dosage form product and sealing it with either a push-through or peelable cover. Adequate heat and pressure must be applied to … Read more
The following factors are used to choose an auditor for vendor qualification: 1. Experience and Qualifications: 2. Technical Proficiency: 3. Auditing Proficiency: 4. Self-reliance and impartiality: 5. References and Reputation: 6. Adherence to Regulatory Mandates: 7. Audit Methodology and Approach: Organizations can choose a skilled auditor to assess vendors and guarantee adherence to industry standards and legal obligations by taking these factors into account.
“Good Laboratory Practice (GLP) is concerned with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported.” GLP prescribes a laboratory to work according to a system of procedures and protocols. This implies the organization of the activities and the conditions under which these take place are controlled, … Read more
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
