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Wednesday, May 13, 2009

CGMP guidelies Current Good Manufacturing Practice Ammendments

CGMP guidelines Current Good Manufacturing Practice Amendments
Dear readers of this website associated with manufacturing of pharmaceuticals
This website is becoming most popular in pharmaceuticals manufacturing and regulatory affairs section in pharmaceuticals ,and amongst pharmaceutical,pharmacy students ,pharmacists around the world ,
we are very happy in serving you all associated with pharmaceuticals manufacturing and regulatory affairs in pharmaceuticals .
I will like to provide some good documents over this website.
So that this website will become your favorite reference library and a very good tool for your all references ,requirements of GMP ,CGMP ,regulatory affairs , all topics associated with pharmaceuticals manufacturing and pharmacy.

FDA has given Current good manufacturing guidelines (cgmp guidelines ) in
21 Code of Federal Regulations
Parts 210 and 211
I will like to provide you a brief about cgmp here
Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Part 210 contains
210.1 Status of current good manufacturing practice regulations.
210.2 Applicability of current good manufacturing practice regulations
210.3 Definitions
PART 211 contains
Subpart A--General Provisions
Subpart B--Organization and Personnel
Subpart C--Buildings and Facilities
Subpart D--Equipment
Subpart E--Control of Components and Drug Product Containers and Closures
Subpart F--Production and Process Controls
Subpart G--Packaging and Labeling Control
Subpart H--Holding and Distribution
Subpart I--Laboratory Controls
Subpart J--Records and Reports
Subpart K--Returned and Salvaged Drug Products
You will find lot of WHO'S cgmp guidelines documents on this website
find it in blog archive on this website on your left hand side on this website.
Here is the link to the CGMP guidlines where you will get detailed information on CGMP (210 CFR 21CFR ).
Further the food and drugs administration has done some amendments in it cgmp guidelines on its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals .
This amendment in rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters.
This rule is effective from December 8, 2008 and is available on FDA'S website.
They have published cgmp guidelines amendments requirements for finished pharmaceuticals which Contains

Summary of the Final Rule
A. Aseptic Processing
B. Asbestos Filters
C. Verification by a Second Individual
D. Other Minor Changes
Comments on the Proposed Rule and FDA’s Response
A. General Comments
B. Plumbing
C. Aseptic Processing
D. Asbestos Filters
Here is the link for CGMP requirements for finished pharmaceuticals amendment PDF format document for your reference.
YOU WILL GET VERY GOOD DOCUMENTS ON GMP GUIDELINES HERE REGULATORY AFFAIRS IN PHARMACEUTICALS

Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

CFR 21 PART 11

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Regulatory Affairs in Pharmaceutical Industry

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