Complete Pharma Solution
REMEDIATION OF DATA INTEGRITY FAILURES Responding to Significant Data Integrity issues Consideration should be primarily given to resolving the immediate issues identified and assessing the risks associated with the data integrity issues. The response by the company in question should outline the actions taken as part of a remediation plan. …
Read More »Classification of data integrity deficiencies
Classification of data integrity deficiencies To aid consistency in reporting and classification of data integrity deficiencies Deficiencies relating to data integrity failure may have varying impact to product quality. Prevalence of the failure may also vary between the actions of a single employee to an endemic failure throughout the inspected …
Read More »Bung Processor / Autoclave
Bung Processor / Autoclave Definition of Autoclave An autoclave is a pressure chamber used to carry out industrial processes requiring elevated temperature and pressure different to ambient air pressure. Autoclave is used in medical application to perform sterilization, and in the chemical industry to cure coatings, vulcanise rubber and for …
Read More »TURN TABLE
TURN TABLE Turntables are horizontal, rotatable powered table mechanisms for transferring material/container between conveyors that are in angular relation to one another. They often provide both loading and unloading of their contents to and from a conveyor. In order to increase productivity and ergonomics in any manufacturing operation, equipment such …
Read More »HPLC Interview Questions
HPLC Interview Questions Question 1: What is Full form of HPLC? Answer: HPLC stands for High-performance Liquid Chromatography or High-pressure Liquid Chromatography. Question 2: What is HPLC Principle? or What is Principle of Chromatography? Answer: It is a chromatographic technique used to separate the components from a mixture of a …
Read More »NITROGEN GAS DISTRIBUTION SYSTEM
NITROGEN GAS DISTRIBUTION SYSTEM WELDING AND CLEANING DETAILS CERTIFICATION Welder will be certified to a qualified welding procedure to be followed. Welder shall be certified in the use of the specific equipment and material being used in the welding process as per agreement with client. 10% of all orbital welded …
Read More »PURIFIED WATER
PURIFIED WATER WELDING AND CLEANING DETAILS CERTIFICATION Welder will be certified to a qualified welding procedure to be followed. Welder shall be certified in the use of the specific equipment and material being used in the welding process as per agreement with client. 10% of all orbital welded connections and …
Read More »QA Interview Frequently Asked Questions
MOST FREQUENTLY ASKED QUESTIONS What parameters are considered during the performance qualification of HVAC? The following parameters are to be considered during the performance qualification of HVAC: 1. Calibration test certificates of instruments 2. Training records of the validation team 3. Pressure drop across the HEPA & fine filters 4. …
Read More »Microbiological Efficacy of the Cycle
Microbiological Efficacy of the Cycle Validation studies that demonstrate the efficacy (lethality) of the production cycle need to estabilished. A sterility assurance of 10 or -6 better should be demonstrated for any terminal sterilization process. The level of sterility assurance should be demonstrated for all parts of the drug product …
Read More »Microbiological Monitoring of the Environment
Microbiological Monitoring of the Environment The microbiological monitoring program shall be performed during routine production and media fills and procedure for microbiological monitoring program are clearly defined in SOP. Microbiological monitoring – frequency of monitoring, type of monitoring, sites monitored, alert and action level specifications, and clearly defined procedure for …
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