SHANGHAI - Following industry comments, China's State FDA released another draft GMP guideline for which it seeks additional public comments. The revised draft offers clarity on a few key points but still leaves huge gaps that will need to be filled slowly over time.

"Compared with the last draft, there are two highlights to further emphasize the drug quality attorney system and aseptic processes," Gao Huijun, director of Shanghai FDA's Institute for Food and Drug Safety, told PharmAsia News.

SFDA released its most stringent ever GMP draft guideline in September that will eventually replace the current version enacted in 1999 (Also see "China Releases Strictest Ever GMP Draft Guidelines; Laxer Standards Urged For Local Companies" - Scrip, 13 October, 2009.).

"The last draft looks kind of awkward since most of the [language] is directly translated from EU guidelines," Gao said. "SFDA learned from feedback on the first version and revised the draft and clarified these points in the new version."

"The industry also questioned whether it is proper to add the drug quality attorney system to the GMP guidelines since it is a new system which may still need more time to practice," Gao noted.

China fully launched the quality attorney system in April (Also see "China Implements New Quality System To Strengthen Drug Safety; Puts Legal Onus On Drug Quality Attorneys" - Scrip, 22 April, 2009.), after a two-year pilot program in Guangdong (Also see "Chinese Province Implements Pilot Quality System To Strengthen Drug Safety" - Scrip, 30 July, 2007.).

That system copies the model in Europe; however there are some gaps between the two systems, according to the director.

"In Europe, only qualified people trained by a specific program can apply for the quality attorney position, but in China there is no such detailed training program," she said.

Instead, local FDAs will train officials assigned by companies to take on the role of quality attorney; however, the training program will not reach the same level of compliance as Europe, according to Gao.

She also said the aseptic processing guideline is too strict because it requires companies to restructure their manufacturing sites to meet the requirements.

"One step to [achieve] the EU standard would be a disaster for Chinese companies that don't plan to renew their plants in the next few years," Gao noted.

Compliance To Come In Small Steps

Any efforts to tighten regulations will take years to achieve compliance, Robert Walsh, Managing Partner from Samsara Biopharma Consulting, told PharmAsia News.

GMP requirements are not clear on processes such as how to characterize cell lines and how to validate viral clearance in the downstream process, according to Walsh, who is in the midst of conducting 127 GMP audits for biologics companies.

"But the devil is in the details," he said. "SFDA can make any regulation it wishes, but these need enforcement. It will be interesting to see how much of a grace period is given for manufacturers to meet standards, or whether certain manufacturers will be 'grandfathered' under old rules."

"For biological manufacturers, the only ones we know of that are for sure ready for tougher and more detailed regulations are the Chengdu and Wuhan Institutes for Biological Products, but this is because they have spent the last three to four years developing two new vaccines to [comply with] strict WHO standards," Walsh added.

"Most MNC's that really know and care put a lot of effort into making sure their Chinese suppliers meet standards," Walsh said.

"The thing with Baxter's problem last year with heparin was an anomaly that could be explained by the fact that it was a couple of layers away from the source, so chain of responsibility was weakened," Walsh noted.

The U.S. Pharmacopeia is taking a forward-looking, risk-based approach to protecting the supply chain for biological drug products from intentional and unintentional adulteration, even as it adds testing requirements aimed at preventing a new heparin crisis.

Recent USP monographs have placed more emphasis on qualifying vendors of raw materials as well as on using risk-based approaches in designing qualification programs. And in its quest to place tighter controls on the supply chain, USP is continuing its efforts to improve identification testing standards for heparin to better identify potential adulterants (Also see "USP Tightens Supply Chain Controls with Risk-Based Vendor Qualification; Aims To Prevent New Heparin Crisis" - Scrip, 3 December, 2009.).

Public comments on the revised GMP guidelines will be accepted until Dec. 20.

- Dai Jialing (j.dai@elsevier.com)

[Editor's note: This article appears courtesy of PharmAsiaNews.com, F-D-C Reports' new site for Asian biotech and pharmaceutical news. Register for a 30-day risk free trial.]

China's FDA Issues Revised GMP Draft Guideline Following Industry Comments; Expects Compliance To Come In Stages

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