Mahummed Asif

Mahummed Asif is an experienced pharmaceutical and Certified six Sigma green belt professional. Author and founder of Pharma share, a pharmaceutical blog. He has rich experience in pharmaceutical quality functions.

Critical Parameters in Blister Packing

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Forming Temperature: The quality of the pockets that form is determined by the forming temperature. It depends on the type of packaging material and the unit’s dimensions. Sealing Temperature: It establishes the outcomes of the leak test. Pressure and plate knurling are both involved. Speed of machine: It varies from machine to machine and is determined by:  i) Product Features: Size, Hardness, Shape, and Dispersible Tablets. b) According to the kind of packing materials that are utilized. Pressure: It influences product quality and can be used for cold forming and blister sealing. Leak Test: Leak test is performed to assess the possibilities of leaks in the blister and all blisters after checking should not contain water inside any pocket. Common Issues in Blister packing:

BASICS OF BLISTER PACKING

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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

Selection criteria for an auditor for vendor qualification / audit

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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 Practices

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“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

Types of Water used in Pharmaceutical Industry

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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

UNDERSTANDING OF BLISTER PACKING IN PHARMACEUTICAL INDUSTRY

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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

Understanding Packing Materials in Pharmaceutical Industry

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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

QUALITY RISK ASSESSMENT

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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

UNDERSTANDING PROCESS VALIDATION APPROACH IN PHARMACEUTICAL INDUSTRY

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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

QbD ELEMENTS

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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