Tag: sterility

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 5)

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| Interview & Placement, Quality Assurance

Interview Questions for Production (Injectable preparation) in pharmaceutical industry (Cipla) Final round of Interview questions in technical round in Parenteral Production (SPV) : 1. Viable and non viable limits for classified area.  2. Acceptable Lux value as per guidelines for visual inspection of filled vials or ampoule. 3. Endotoxin, Bioburden, TOC Limits of WFI comparison […]

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Guidelines for viable & non -viable counts in gmp areas (As per WHO,2011)

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| Drug regulatory and guidelines, News Updates, Quality Assurance, Validation

Manufacture of sterile pharmaceutical preparations, four grades of clean areas are distinguished as follows: Grade A: The local zone for high-risk operations, e.g. filling and making aseptic connections. Normally such conditions are achieved by using a unidirectional airflow workstation. Unidirectional air flow systems should provide a homogeneous air speed of 0.36–0.54 m/s (guidance value) at […]

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Review – Quality control of parenteral products

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| fnd and production, Quality Assurance

ABSTRACT: In a pharmaceutical organization a quality control deals with testing, sampling, specification, and documentation, release procedure which ensure that all tests are actually carried out prior to release of material for sale or use. Four basic area of testing parenteral are Sterility, Freedom form Pyrogens, Freedom from particulate matter and leakers. The achievement of […]

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Vaccine manufacturing process

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| fnd and production, Quality Assurance

Vaccines are a group of pharmaceuticals that include some of the oldest biologically-made compounds. The Smallpox vaccine was introduced by Edward Jenner as early as in 1796 and Louis Pasteur created the first live attenuated bacterial (Chicken Cholera) and viral (Rabies) vaccines at the end of the 19th century. A vaccine contains an antigen that […]

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Filtration Technique

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| fnd and production, Quality Assurance

Filtration is a common method of sterilizing drug product solutions. An appropriate sterilizing grade filter is one which reproducibly removes all microorganisms from the process stream, producing a sterile effluent. Such filters usually have a rated porosity of 0.2 micron or smaller. Whatever filter or combination of filters is used, validation should include microbiological challenges […]

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Part III: Qualification of Water and Air Handling Systems

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| Quality Assurance, Validation

B. Validation life cycle 1. Determination of Quality Attributes In performing the validation, defining the quality attributes—that is, gaining a clear understanding of the required quality and intended use—is the most important issue, and should be determined before starting the validation. Without defining required quality attributes we cannot establish validation protocols, which are the basis […]

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Part II: Qualification of Water and Air Handling Systems

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| Quality Assurance, Validation

II. VALIDATION STRATEGY A. Validation Concept To prove the performance, one must demonstrate (document) that the processes or systems consistently produce the specified quantity and quality of water and/or air when operated and maintained according to specific written operating and maintenance procedures. In other words, validation involves proving 1. Engineering design 2. Operating procedures and […]

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