Tag: PRES
Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 4)
Interview Questions for Production (Injectable preparation) in pharmaceutical industry Final round of Interview questions in technical round in Production (SPV) : 1. Principle of Autoclave operation. 2. Basics of cleaning validation during change over of different product in filling. 3. How to take swab from filling needle in filling machine ? 4. Handling of filters […]
Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 5)
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 […]
Guidelines for viable & non -viable counts in gmp areas (As per WHO,2011)
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 […]
Review – Quality control of parenteral products
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 […]
Distinguish between dissolution and disintegration
Disintegration time is the time required for a dosage form to break up in to granules of specified size (or smaller) under carefully specified conditions. Where as dissolution is a process by which solid substance enters in the solvent to yield a solution.It is controlled by the affinity between the solid substance and the solvent. In other […]
High Efficiency Particulate Air (HEPA)
An essential element in ensuring aseptic conditions is the maintenance of HEPA filter integrity. Integrity testing should be performed at installation to detect leaks around the sealing gaskets, through the frames or through various points on the filter media. Thereafter, integrity tests should be performed at suitable time intervals for HEPA filters in the aseptic […]
Vaccine manufacturing process
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 […]
Filtration Technique
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 […]
Part IV: Qualification of Water and Air Handling Systems
3. Steps of Validation Validation plans for water and air systems typically include the following steps: 1. Establishing standards for quality attributes of water and air to manufacture pharmaceuticals. 2. Defining systems and subsystems suitable to produce the desired water and air by considering the quality grades of water and air. 3. Designing equipment, controls, […]