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Outlook: What will bring the GMP Year 2016?

展望：2016年GMP有何新進(jìn)展？

The previous year 2015 was an eventful year. Again there were new developments in the GMP environment as well as announcements of changes that preoccupied the pharmaceutical industry. 2016 won't be less exciting, also because now many of the new requirements must be implemented. But aso novelties have to be expected. Here are a few highlights:

之前的2015年是多事的一年。在GMP環(huán)境再次有新的發(fā)展，制藥行業(yè)也有不少變化宣布。2016年也不會(huì)差，也因?yàn)楝F(xiàn)在許多新的要求必須實(shí)施了。還有一些創(chuàng)新值得期待。這里講一些重點(diǎn)內(nèi)容。

A new Annex might be added to the EU GMP Guide: Annex 21 for "Importers of Medicinal Products". The current concept paper doesn't reveal much information but a first draft of the new Annex can be expected soon for public consultation. The discussions of the requirements for import in the context of the revision of Annex 16 ("Certification by a QP and Batch Release") were the impulse for the new document. The future Annex is aimed at importers and will cover requirements regarding import activities which are not part of other GMP regulations so far.
EU GMP指南中可能會(huì)增加一個(gè)新的附錄：附錄21“藥品進(jìn)口商”。目前的概念文章并沒有透露出許多信息，但可以期待新附錄的第一版草案會(huì)很快公布征求意見。在附錄16（QP證明和批放行）修訂后，對(duì)進(jìn)口要求的討論是新文件產(chǎn)生的原因。將來的附錄針對(duì)的是進(jìn)口商，會(huì)包括關(guān)于進(jìn)口活動(dòng)的要求。這些進(jìn)口活動(dòng)截止目前并不在其它GMP法規(guī)里面。

A concept paper on Annex 1 of the EU GMP Guide (Manufacture of sterile Medicinal Products) is currently running. A first draft of the revised Annex should also be expected soon for public consultation. The revision is not supposed to create new expectations, but it will contain some adjustments like for example the consideration of other international sets of rules (FDA Aseptic Guide, ICH Q8, Q9, and Q10) and the clarification of requirements which have been until now controversial or ambiguous.  The US-American IEST published the new version of ISO 14644:2015 "Classification of air cleanliness by particle concentration" already last year. It is to be expected that also here the contents will be considered.

EU GMP指南附錄1的概念文章（無菌藥品的生產(chǎn)）正在進(jìn)行中。預(yù)期修訂附錄的首版草案很快就會(huì)公布征求意見。修訂版并不會(huì)創(chuàng)建新的要求，但會(huì)包括許多調(diào)整，例如考慮其它國(guó)際規(guī)定（FDA無菌指南，ICH Q8，Q9和Q10），以及對(duì)規(guī)定要求的澄清，這些要求到目前為止還是相互矛盾或模糊不清的。美國(guó)IEST新版本ISO 14644：2015“根據(jù)顆粒濃度進(jìn)行空氣清潔度分類”已于去年公布。其內(nèi)容也是需要考慮的。

Annex 17 of the EU GMP Guide (Real Time Release Testing) is to be completely modified. The change of name alone in the current draft signalises a complete reorientation. In the end, the curent annex 17 "Parametric Release" was restricted to be used for the routine release of products sterilised in the final container without sterility tests on the basis of sterilisation parameters. Now, the revision also includes the implementation of the principles of ICH Q8, Q9, and Q10 which can also be applied to other products. Afterwards certification and release of a batch can be based on the monitoring and the control of critical process parameters and relevant material characteristics, sufficient product and process knowledge and a combination of in-process monitoring and controls which provide sufficient data. Then, a batch release would be justifiable without re-testing a sample of the finished product. For this purpose, the Real Time Release approach must be part of the marketing authorisation. The performance of finished product analytics won't be accepted if the RTR test approach has delivered unfavourable or non-compliant results.

EU GMP指南附錄17（實(shí)時(shí)放行測(cè)試）將要進(jìn)行完全修訂。目前的草案對(duì)名稱的改變就預(yù)示著其完全不同的定位。在結(jié)尾，現(xiàn)行附錄“參數(shù)旅行”被限制于用于在最終包裝里滅菌的藥品的根據(jù)滅菌參數(shù)進(jìn)行常規(guī)放行，不需要進(jìn)行無菌測(cè)試。現(xiàn)在，修訂版本也包括ICH Q8，Q9，Q10概念的實(shí)施，它們也適用于其它藥品。之后的認(rèn)證和批放行可以是根據(jù)對(duì)關(guān)鍵工藝參數(shù)和相關(guān)物料屬性、充分的藥品和工藝知識(shí)和中控監(jiān)測(cè)和提供足夠數(shù)據(jù)的控制的結(jié)合。這樣不需要對(duì)成品進(jìn)行取樣再次測(cè)試也可以判定是否對(duì)批次放行。為此，實(shí)時(shí)放行方法必須是上市許可的一部分。如果RTR測(cè)試方法顯示出不好或不符合的結(jié)果，則成品分析的結(jié)果不能被接受。

The US Food and Drug Administration (FDA) has started an initiative to use so-called Quality Metrics for planning its risk-based inspections. A first draft was published in July 2015 for consultation from associations and the industry. FDA's wish is - after the entry into force - to collect defined quality characteristics i.e. "Quality Metrics" from manufacturers via an electronic portal. With these metrics, the FDA will calculate specific statistics which should enable a risk-based management and planning of FDA's inspections.

美國(guó)FDA已開始倡議使用所謂質(zhì)量量度用于計(jì)劃其基于風(fēng)險(xiǎn)的檢查。首版草案于2015年7月公布征求協(xié)會(huì)和行業(yè)的意見。FDA的希望是，在實(shí)施之后 ，通過電子端口從生產(chǎn)商處收集指定的質(zhì)量屬性，即“質(zhì)量量度”。根據(jù)這些量度，F(xiàn)DA會(huì)計(jì)算指定的統(tǒng)計(jì)指標(biāo)，根據(jù)這些指標(biāo)來進(jìn)行基于風(fēng)險(xiǎn)的管理，制訂FDA檢查計(jì)劃。

Concerning this, a "Quality Metrics Technical Conformance Guide" should be released in 2016. This is referred to in the list of all guidelines published by the CDER (Center for Drug Evaluation and Research) which are planned this year. The list comprises 102 documents in total divided into 15 categories. The following documents should be highlighted:

FDA在2016年要公布“質(zhì)量量度技術(shù)符合性指南”。參見CDER公布的本年度計(jì)劃指南清單。該清單總共包括102個(gè)文件，分為15類。以下文件需要引起注意：

In the category "Pharmaceutical Quality/Manufacturing Standards (CGMP)":

在類別“藥品質(zhì)量/生產(chǎn)標(biāo)準(zhǔn)（CGMP）”中：

• cGMP Data Integrity, Questions and Answers

  cGMP數(shù)據(jù)完整性，問答

• Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products (Revised Draft)

  單次使用包裝的固體口服制劑藥品有效期（修訂草案）

• Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities

  藥房和外包設(shè)施生產(chǎn)的特定藥品的重新包裝

And in the category "Pharmaceutical Quality/CMC":

在“藥品質(zhì)量/CMC”類中：

• Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing

  非無菌藥品生產(chǎn)中的微生物質(zhì)量考慮

• Quality Metrics Technical Conformance Guide mentioned above.

  上述質(zhì)量量度技術(shù)符合性指南

Some of these documents were already in the list for 2015. It remains to be seen what will come.

其中一些文件已經(jīng)在2015年的清單里，因此說還是要看最后哪些會(huì)真的被制訂。

There will be some new developments in the area of Investigational Medicinal Products (IMPs). Last year, the EU Commission published four new public consultations on IMPs. They concern both manufacturing (GMP) as well as clinical trials (GCP) for human medicinal products. The reason is that as soon as Regulation (EU) No 536/2014 will apply to clinical trials, Directive 2003/94/EG won't be applicable to IMPs any longer. Then, they will have to be manufactured or imported according to the regulations of Delegated Acts or other specific regulations; in other words, new documents have to be created. This could also endanger Annex 13.  The question is currently discussed to drop it and replace it with another legal act or to revise it.

在非臨床藥品（IMPS）領(lǐng)域有一些新的發(fā)展。去年，歐盟委員會(huì)公布了IMP的4份新文件征求意見。這些文件兼有人用藥品的生產(chǎn)（GMP和臨床試驗(yàn)（GCP）。其理由是一旦法規(guī)EU 536/2014適用于臨床試驗(yàn)，指令2003/94/EC就不再適用于IMPS了。這樣，他們就不得不按委托監(jiān)管法案或其它指定法規(guī)的規(guī)定進(jìn)行生產(chǎn)或進(jìn)口了。換句話說，必須創(chuàng)建新的文件。這可能會(huì)讓附錄13陷入危機(jī)?，F(xiàn)在正在討論的問題是不要管它，而采用另一個(gè)法案來替代或修訂之。

【來源】Julia Blog

【整理】TACRO