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
880
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 …
Read More »
April 11, 2020
Coronavirus updates, Link For Guideline, Question Forum
922
Questions and Answers on coronaviruses (COVID-19) WHO 1.0 Question : What is a coronavirus? Answer : Coronaviruses are a large family of viruses which may cause illness in animals or humans. In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases …
Read More »
January 21, 2020
Audit and Guideline, Audit and Routine Checklist, Question Forum
1,407
The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection FDA Expectations • FDA conducts inspections to assess compliance with applicable laws and regulations • FDA expects: – Investigators to conduct inspections in a reasonable manner – Industry to …
Read More »
March 21, 2019
Audit and Guideline, Question Forum
1,011
Question and Answers on WHO GMP Why is GMP important? Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. Poor quality medicines can damage health A poor quality medicine may contain toxic substances that have been unintentionally added. A …
Read More »
February 20, 2018
Audit and Guideline, Question Forum
826
Questions and answers EU GMP guide annexes: Supplementary requirements 1. How should the integrity of sterilising filters be verified? H+V June 2007 Annex 1, paragraph 85 states, ‘the integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such …
Read More »
February 19, 2018
Audit and Guideline, Question Forum
709
Questions and answers Basic requirements for active substances used as starting materials: GMP compliance for active substances 1. How can GMP compliance for active-substance manufacturers be demonstrated? H+V April 2011 Directive 2001/83/EC as amended (Directive 2001/82/EC for veterinary medicinal products) states that manufacturing-authorisation holders are obliged to use, as starting materials, only active substances that have been manufactured …
Read More »
February 18, 2018
Audit and Guideline, Question Forum
2,355
Questions and answers on Data integrity Data integrity Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities.It is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, applying equally to manual (paper) and electronic systems. Promotion of a quality culture together with implementation …
Read More »
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 …
Read More »
April 8, 2016
Question Forum
689
Good Laboratory Practice Regulations — Questions and Answers (I) Bar Code Label Requirements – Questions and Answers ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India …
Read More »
March 31, 2016
Question Forum
1,129
Question & Answer on ICH Question and Answer on ICH Q7 Question and Answer on Q8 ,Q9 and Q10 For More Pharma Updates Visit –https://pharmaguidances.com Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years …
Read More »