December 2, 2020
2016, 2017, 2018, 2019, 2019, 2020, API, Astrological Video, Audit and Guideline, Audit and Routine Checklist, Beauty tips, Cleaning Validation(CV), Computer System Validation, Coronavirus updates, Cosmetics and pharmaceutical, Design Qualification, Diet and Nutrition, Discount Coupon, Drug and supplements, DRUGS AND COSMETICS ACT 1940 AND RULES 1945, Education in Ukraine, email, Engineering, Factory Acceptance Test, FDA News, Featured, FINISHED PRODUCT, Fitness News, Flipkart, Health news, HR SOP, Innovator Medicines Details, Installation Qualification(IQ), Jobs, Latest News, Link For Guideline, Master Formula, Microbiology, Motivational & Social Video, Operational Qualification(OQ), Other, Other Topic, Other Topic, Other Topic, Other Topic, Other Topic, other video, Performance Qualification(PQ), Presentation, Presentation, Presentation, Presentation, Presentation, Process Validation(PV), Production, QA & QC, Qualification, Quality Assurance, Quality Assurance, Quality Control, Question Forum, Question Forum, Question Forum, Question Forum, Revalidation/requalification, Risk Assesment, Risk Assessment, Site Acceptance Test, Social Awareness, SOP, SOP, SOP, SOP, User Requirement Specification(URS), USFDA WARNING LETTER, Validation, Validation & Qualification, Warehouse, Water for Pharmaceutical use
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All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride …
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February 14, 2018
email, Other Topic, Production
771
Human interventions in aseptic processing It is appropriate to focus on human interventions performed during aseptic processing because no other factor has the same potential for introducing contamination. Sterilization processes, environmental sanitization, room design, and heating and ventilation systems are all substantially less significant as sources of contamination. Personnel continuously shed microorganisms and particles to …
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February 12, 2018
Audit and Guideline, email, Other Topic
1,049
Non-sterile process validation as per WHO Technical Report Series, No. 937 1. Principle 2. Scope 3. General 4. Prospective validation 5. Concurrent validation 6. Retrospective validation 7. Revalidation 8. Change control Principle Process validation provides documented evidence that a process is capable of reliably and repeatedly rendering a product of the …
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February 11, 2018
Audit and Guideline, email, Other Topic
915
Validation of computerized systems 1. General 2. System specification 3. Functional specification 4. Security 5. Back-ups 6. Validation 7. Validation of hardware and software 7.1 Hardware 7.2 Software General Computer systems should be validated at the level appropriate for their use and application. This is of importance in production as well …
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February 8, 2018
Audit and Guideline, email, Other Topic
1,132
Analytical method validation as per WHO Technical Report Series, No. 937 Principle General Pharmacopoeial methods Non-pharmacopoeial methods Method validation Characteristics of analytical procedures Principle This appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in this appendix may be followed …
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February 8, 2018
Audit and Guideline, email, Other Topic
1,327
Cleaning validation protocols Cleaning validation should be described in cleaning validation protocols,which should be formally approved, e.g. by the quality control or quality assurance unit. In preparing the cleaning validation protocol, the following should be considered: — disassembly of system — precleaning — cleaning agent, concentration, solution volume, water quality — time …
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February 3, 2018
Audit and Guideline, email, Question Forum
3,834
Stability Testing of Drug Substances and Products A. General QUESTIONS 1: What is the scope of and implementation date for the FDA stability guidance? ANSWERS 1: The FDA stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances …
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February 1, 2018
Audit and Guideline, email, Other Topic
1,089
Qualification as per WHO Technical Report Series, No. 937 Qualification should be completed before process validation is performed. The process of qualification should be a logical, systematic process and should start from the design phase of the premises, equipment, utilities and equipment. Depending on the function and operation of the equipment, utility or …
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February 1, 2018
Audit and Guideline, email, Other Topic
2,895
Validation as per WHO Technical Report Series, No. 937 Approaches to validation Two basic approaches to validation — First is based on evidence obtained through testing (prospective and concurrent validation), and Second is based on the analysis of accumulated (historical) data (retrospective validation). Whenever possible, prospective validation is preferred. Retrospective validation is no …
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January 29, 2018
Audit and Guideline, email, Link For Guideline
3,363
Investigating Out-of-Specification This topic provides how to evaluate out-of specification (OOS) test results. the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process …
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