WHO WHO Technical Report Series?

WHO Guidelines for Pharmaceuticals

  • Process validation.
  • Cleaning validation.
  • Analytical method validation.
  • DQ, IQ, OQ, PQ of equipment.
  • Water system validation.
  • HVAC validation.
  • Computer system validation.
  • Market complaint handling.

Who is TRS 981?

Annex 2 of the new Technical Report 981 is a new WHO guideline on the implementation of a quality risk management system. The aim of this guideline is to assist the implementation of a QRM system, covering activities such as development, manufacturing, sourcing of materials, testing, packaging and storage.

What is QMS in pharma?

Quality management system in pharmaceuticals helps to improve the product quality and minimize the risk of product recall. Quality Management System takes into account all applicable guidelines and regulations that are designed to maintain its robustness. …

WHO is TRS 961?

WHO Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (Annex5, TRS 961) Content: These guideline focuses primarily on the design and good manufacturing practices (GMP) requirements for HVAC systems for facilities for the manufacture of solid dosage forms.

WHO TRS 937 process validation?

937. Process validation provides documented evidence that a process is capable of reliably and repeatedly rendering a product of the required quality. The principles of planning, organizing and performing process validation are similar to those for qualification.

What is 21 CFR Pharma?

21 CFR Rules are a set of rules which govern or regulate the management and usage of electronic records in pharmaceuticals and medical devices. … For this reason, the data security and integrity as per 21 CFR rules relate to how these rules guide the management of electronic records as well as electronic signatures.

WHO GMP main principles for pharmaceutical products?

1.1 Principle. The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy.

Who TRS guideline for hold time study?

According to WHO TRS 992 “Annex 4 General guidance on hold-time studies” hold time study should be done in granulation, drying, lubrication, core tablet, coating solution and coated tablet stages. Manufacturer should prepare a flowchart of sampling for the hold time analysis.

WHO guideline No 961 Annex 7?

961, 2011, Annex 7. These guiding principles on transfer of technology are intended to serve as a framework which can be applied in a flexible manner rather than as strict rigid guidance. Focus has been placed on the quality aspects, in line with WHO’s mandate…

What is the schedule M?

Schedule M is a part of Drug and Cosmetic act 1940. It is GMP for pharmaceuticals that should be followed by pharmaceutical manufacturing units in India.

WHO GMP certified companies in India?

List of WHO GMP certified companies in India (Medicines, 2021)

  • Acme Formulation Pvt. Limited.
  • Ajanta Pharma Ltd.
  • Aurobindo Pharma Ltd.
  • Cadila Pharmaceuticals Ltd.
  • Cipla Ltd.
  • Emcure Pharmaceuticals Ltd.
  • Hetero Labs Ltd,
  • HLL Lifecare Limited.

WHO GMP for biological products?

Good manufacturing practices (GMP) for biological products were first published by WHO in 1992 (1). This current revision reflects subsequent developments that have taken place in science and technology, and in the application of risk-based approaches to GMP (2–14).

WHO GMP certificate meaning?

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

What is 483 in pharma?

A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

What is Alcoa in pharma?

ALCOA in pharmaceuticals has been defined by the U.S. FDA as Attributable, Legible, Contemporaneous, Original and Accurate. This is applicable to all form of evidence including electronic, paper-based and hybrid.

What is Alcoa and Alcoa Plus?

Ankur ChoudharyPrintQuestion Forum 14 comments. The term Alcoa is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. Alcoa was then expanded to Alcoa Plus (Alcoa +), by the addition of a few more concepts which are; Complete, Consistent, Enduring and Available.

WHO TRS for qualification?

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.

WHO guideline for process validation?

961, Annex 6 (3).) A risk‑based and life‑cycle approach to validation is recommended. Thorough knowledge of product and process development studies; previous manufacturing experience; and QRM principles are essential in all approaches to process validation, as the focus is now on the life‑cycle approach.

Who is responsible for performance qualification?

But the reality is, performance qualification should be performed by both the equipment manufacturers as well as their clients, the pharmaceutical companies. Performance qualification is a part of equipment validation process and there are a number of reasons why pharmaceutical plants should perform it.

Who good practices pharmaceutical microbiological laboratories?

1 Microbiology laboratories and certain support equipment (e.g. autoclaves and glassware) should be dedicated and separated from other areas, especially from production areas. 2.1. 2 Microbiology laboratories should be designed to suit the operations to be carried out in them.

WHO GMP certified third party manufacturer?

Taj Pharmaceuticals, one of the leading WHO GMP certified Manufacturing Third Party Manufacturers India brings the best-quality products. The company carries the rich experience in the niche manufacturing of WHO GMP certified Manufacturing Third Party.

Who needs GMP certification?

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.


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