GMP

All posts tagged GMP

2016-03-30_08-03-13

The latest version of the Eudralex Volume 4, Good manufacturing practice (GMP) Guidelines can be found at this link:

http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

It’s well worth having a look at to see how GMP documents, such as the site master file, can be laid out.

The Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors (familiarly known as the Orange Guide) is an essential reference work for all those involved in the manufacture or distribution of medicines in or for Europe. It is compiled by the UK drug regulatory body, the MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It therefore contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation.

 

The Orange guide is not available for free access but a sample chapter on premises and equipment can be found here. A full list of its index is also available here.

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book)  is a list that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).

Did you know that when the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, “It’s almost Halloween. How about orange?” Before long, The Orange Book had become a popular short title for this important publication. Courtesy FDA

The downloadable Orange Book “list” can be found here:

http://www.fda.gov/drugs/informationondrugs/ucm129689.htm

The link below shows a specification sheet outlining an SOP on how to calibrate a pH meter. It includes information on the expected pH Buffer Values at Various Temperatures since pH is affected by temperature.

pH meter calibration

Below are links to documents and websites showing “some” of the regulations for GMP in relation to Premises and Equipment from the EU, WHO and FDA

EU guidelines for Premises and Equipment

FDA guidelines on GMP for Premises and Equipment (Filters)

WHO guidelines on GMP for Premises (Section 12) and Equipment (Section 13)

 

 

 

The link below is an example of a site master file (SMF).

Site_Master_File_

Here is some advice on drafting a SMF from the WHO:

http://apps.who.int/prequal/info_general/documents/TRS961/TRS961_Annex14.pdf

The following links are examples of quality policy documents outlining the objectives of the companies.

Example 1 Alcatel-Lucent Quality Policy

Example 2 Alpha Plus Quality Policy

Below is a link to a pdf of a table of contents from a Honda Supplier Quality Manual. It shows many of the components of a quality manual as outlined in class including:

  • Introduction and Company Profile.
  • Policy and Objectives
  • Definitions
  • Quality system which applies in the company
  • Organization
  • Authority and Responsibilities
  • Process Control
  • Inspection and Testing
  • Validation
  • Calibration
  • Records
  • Training
  • Product release
  • Non-conforming Items

Honda Supplier Quality Manual

Here is a link on the FDA website of an example of a warning letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm369495.htm

25-09-2013 13-25-30

And some more info and FAQ’s related to FDA 483 forms and Warning Letters

http://en.wikipedia.org/wiki/Form_FDA_483

https://en.wikipedia.org/wiki/FDA_Warning_Letter

http://www.fda.gov/ICECI/EnforcementActions/ucm256377.htm