Science and quality management

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Showing posts from July, 2020

An overview of bioequivalance

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Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs) In India and Scheme for Promotion of Bulk Drug Parks.

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GMP/GDP information sources (ECA Academy)

Dear users, Though this link, you can get GMP related guidelines, warning letters updates and many cerfication course s...... Click here to tour.....

EFFECTIVE AND FAST APPROVAL OF INCIDENT INVESTIGATION REPORTS

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Designing a biologics manufacturing facility: Early planning for success

This article reviews important steps in the manufacture of biologics. The authors provide planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC). They pose important questions manufacturers should address, from facility issues to working with a contract development manufacturing organization. They conclude that trends toward reducing the time to market put considerable stress on all aspects of commercial operations and commercial scale manufacturing process development, making early tactical and strategic planning essential. Introduction The drug manufacturing facility environment presents one of the major sources of potential contaminants in the final biologic drug product. It is therefore critical to design facilities with clean-room environmental controls and monitoring that adhere to the highest standards of CGMP quality guidelines. This is particularly true, given that many cell and gene th

Scheme for promotion of medical devices park....

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New EMA pharmaceutical water quality guideline takes effect February 2021

The European Medicines Agency (EMA) on Monday issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021. Download here....

The Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 53 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia). Downloads

GMP-European commission

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

5Ps for powerful pathalogist

A Pathologist should have to cultivate and implement "5Ps" in his practice. 1. Policy 2. ProcesS 3. Procedure 4. Practice 5. Patient safety

Good documentation practice

Establishment of GMP Facilities in the pharmaceutical industry

Design operation maintenance of GMP Facilities

Things to consider when choosing pharmaceutical machinary

PHARMA PRO&PACK – an official quarterly magazine of the Indian Pharma Machinery Manufacturers’ Association (IPMMA)

Opertunities in the establishment of new MSME

PHARMA PRO&PACK – an official quarterly magazine of the Indian Pharma Machinery Manufacturers’ Association (IPMMA)

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems

Does not affect FDA-approved uses for malaria, lupus, and rheumatoid arthritis July 1, 2020 Update : A summary of the FDA review of safety issues with the use of hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19 is now available. This includes reports of serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, and liver problems and failure.