Source: https://www.gmp-compliance.org/gmp-news/fda-modifies-cgmp-guide-new-text-published
Timestamp: 2019-11-15 14:58:21
Document Index: 592028687

Matched Legal Cases: ['ART 210', 'art 210', 'ART 211', 'art 211', '§ 211', '§ 211', '§ 211']

FDA Modifies cGMP Guide - New Text Published - ECA Academy
FDA Modifies cGMP Guide - New Text Published
FDA Modifies cGMP Guide – New Text Published
On 4 December 2007 the US Food & Drug Administration (FDA) has published changes to the cGMP Guide. We already reported about the planned measures in our News from 25 October 2007. They were also presented by Fred Blumenschein from the authority on the occasion of the 2nd European GMP Conference end of June in Heidelberg, Germany, which was organised by the ECA and the European QP Association.
With the announcement of the new text the FDA also withdrew the "proposed rule" from 1996. This proposed rule contained major modifications of the cGMP Guide. However, a FDA working group found out, that the planned changes are not compliant with the authority's new risk based approach for the 21st Century any more.
On the one hand the FDA intends to substantiate certain requirements with the changes. On the other hand it wants to accomplish an incremental approach to modernisation of cGMP. The modified guide is then supposed to comply with the FDA initiative for the 21st Century.
For instance, one change affects the area "Aseptic Processing". With this regard the FDA has published the Guidance for Industry "Sterile Drug Products Produced by Aseptic Processing" in September 2004. This document was developed following an analysis of the GMP Harmonisation Analysis Working Group. One part of the analysis was a comparison with the EC GMP Guide. Now the FDA has implemented the necessary concretion in the cGMP Guide and has matched it more to the September 2004 Guidance. The new text is not surprising, because it mainly contains requirements that have been interpretations of the authority for several years. However, now the FDA also established the legal scope.
The changes listed below become effective on 17 April 2008. Comments can be provided until 19 February 2008. If there are no essential comments that will prevent the authority from implementing the new content, the FDA will issue an announcement in the Federal Register on 18 March 2008 which will confirm the mentioned due date.
Following you'll fin the new texts:
PART 210-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
■ 1. The authority citation for 21 CFR part 210 continues to read as follows;
■ 2. Section 210.3 is amended by revising paragraph (b)(6) to read as follows:
(6) Nonfiber releasing filter means any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the
component or drug product that is being filtered. * * * * *
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
■ 3. The authority citation for 21 CFR part 211 continues to read as follows:
■ 4. Section 211.48 is amended by revising paragraph (a) to read as follows:
■ 5. Section 211.67 is amended by revising paragraph (a) to read as follows:
(a) Equipment and utensils shall be cleaned, maintained, and sanitized and/ or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
■ 6. Section 211.68 is amended by adding paragraph (c) to read as follows:
(c) Such automated equipment used for performance of operations addressed by §§ 211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the requirements included in those sections for the performance of an operation by one person and checking by another person if such equipment is used in conformity with this section and one person verifies that the operations addressed in those sections are performed accurately by such equipment.
■ 7. Section 211.72 is revised to read as follows:
■ 8. Section 211.82 is amended by revising paragraph (b) to read as follows:
■ 9. Section 211.84 is amended by revising paragraphs (c)(1), (d)(3), and (d)(6) to read as follows:
■ 10. Section 211.94 is amended by revising paragraph (c) to read as follows:
■ 11. Section 211.101 is amended by revising paragraphs (c) and (d) to read as follows:
(3) The containers are properly identified. If the weighing, measuring, or subdividing operations are performed by automated equipment under § 211.68, only one person is needed to assure conditions of paragraphs (c)(1), (c)(2), and (c)(3) of this section have been met.
■ 12. Section 211.103 is revised to read as follows:
■ 13. Section 211.110 is amended by revising paragraph (a) introductory text and by adding paragraph (a)(6) to read as follows:
(6) Bioburden testing. * * * * *
■ 14. Section 211.113 is amended by revising paragraph (b) to read as follows:
■ 15. Section 211.160 is amended by revising paragraph (b)(1) to read as follows:
■ 16. Section 211.182 is revised to read as follows:
A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 211.68, only the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
■ 17. Section 211.188 is amended by revising paragraph (b)(11) to read as follows:
Source: http://www.fda.gov/cber/rules/amendcgmp.pdf