2009年10月17日星期六

Pharmaceutical GMP Laboratory Seminar

I attended the seminar entitled “Effectively Managing a Pharmaceutical GMP Laboratory” organized by SGS on 16th October 2009. It was found very useful and summarized in follows.

In the beginning, Mr. Andy Fung (Project Manager – Systems & Services Certification) briefed the seminar agenda and pointed out Green concept could be applied to the Pharmaceutical Industry.


The first speaker was Dr. Joan Chan (Technical Development Manager from Healthcare and Pharmaceutical Dept., Life Science Services, SGS) and her topic was “Quality Control (QC) in GMP Laboratory”.

Dr. Chan discussed the raw material testing and shared experience on verification of Certificate of Analysis (CoA), as well as in-process testing, finished product testing and release.

What is CoA? She explained it is an authenticated document, which should be issued by a qualified firm. CoA is used to certify the quality and purity of drug substances or drug product being exported.

Dr. Chan also introduced their test program. She informed that the volatile organic impurity was effective in USP (Reference: USP 32, 2009 Monographs). It implies more test items required for pharmaceutical manufacturing.

After that, she discussed “the documentation for recording, analyzing and checking of results” and affirmed traceability was the most critical including sample label (storage condition), reference standard code, weight, temperature, time, glassware, test solution, instrument records, etc.

The last topic in Dr. Chan’s speech was how to conduct out-of-specification (OOS) investigations.

The definition of OOS is “A result related to a chemical or microbiological testing which fails to meeting the specification or criteria”. OOS could be come from material, active pharmaceutical ingredient (API), finished product or the manufacturing environments. (Reference: Investigating OOS Test Results for Pharmaceutical Production – issued by US FDA, Centre for Drug Evaluation and Research (CDER))

During OOS investigation, it separates into two phases.
The first phase is “Laboratory investigation” in which Analyst and Lab supervisor should investigate the root cause of problem. And, the investigation result should be documented. If evidence of laboratory error is observed, repeat the test. If not, the second phase “Full-scale OOS investigation” should be initiated. It covers manufacturing, process development, maintenance and engineering aspects.

Dr. Chan defined Retesting and Resample as follow table.

Finally, Dr. Chan concluded that a batch failure investigation must be extended to other batches or products if OOS is confirmed. If no conclusion can be drawn, the Authorized Person should take the final decision for the batch to be release or not.


The second speaker was Ms. Cherry Lau (Sr. Technical Executive, Systems and Services Certification, SGS) and her presentation was “Overview of a Microbiology Laboratory at a Pharmaceutical Plant”.


In the beginning, Ms. Lau introduced some basic apparatus used in microbiological laboratory. She focused on microbial identification on objectionable organisms such as Staphylococcus aures, Escherichia coli, Pseudomonas aeruginosa, Candidas allbicans, Salmonella spp., and Bile-tolerant gram-negative bacteria, etc.

There are two types of identification: Phenotypic and Genotypic.
Phenotypic identification uses techniques of Morphology and Enzymatic activities. Some examples are shown below.
- Catalase Test (Hydrogen peroxide)
- Oxidase Test
- Coagulase Test
- Commercial Identification System such as API (up to days), Vitek (overnight) and Biolog (4 to 18 hrs)

Genotypic identification uses gene sequencing techniques such as DNA-DNA hybridization, PCR, 16s & 23s rRNA gene sequency, Gas Chromotography (MIDI), etc.

Then Ms. Lau shared microbiological testing information in water sample. For Total Viable Count (TVC), it uses filtration (0.45um & 50mm filter). For Endotoxin test, it used LAL test (Limulus amebocytes lysate) which needs 5 points standard calibration curve; or KQCL (Kinetic Chromogenic LAL Assay). (Seminar related LAL testing.)

Environmental Monitoring in clean room / laboratory area were also introduced. The following items were valuable to be considered.
Where to place settle plates? It suggested using worse case for sampling.
Where to swab, how big an area?
Where to take air sample for airborne viable counts?
Is gowning qualified?


Lastly, Ms. Lau shared her inspection experience at a sterile vaccine manufacturing site as follows:
i) Staff is not allowed to enter production area after accessing Microbiology Lab on the same day.
ii) Each operator has a settle plate to monitor his operation throughout his working session, and followed by finger dab plates and documented in filing record.
iii) Temperature monitoring should be performed (Media plates should be stored under 25C).
iv) Sanitization of filtration manifold by chemical is effective. UV or autoclaving is not required.
v) Exception report would be issued if there is change in microflora or out of trend.

Valuable website recommended by speaker: http://www.microbiologyforum.org/ .

2 則留言:

鹿米館 說...

資料詳盡,頗有意思,其實有想法是創意產業如何和品質管理上合作,因為雖然創意是天馬行空,但是某程度上也要有品質去監管才可以「升呢」先得。

P.S.你去黃生個blog提相反意見,更見佩服。

Quality Alchemist 說...

多謝你的意見.
創意產業和品質管理的合作,要講求平衡. 在不同階段有不同的比重, 都是值得研究.

我和黃生在某個博客中辯論, 各有理據和立場. 之後才到他的網誌觀看文章. 他對某些命題及某些博客的批評比較偏激. 但他的文章是值得參考, 雖然不大同意他的立場. 整體上來說,大家都是理性辯論.

我沒有打算在網誌寫時事及政治評論, 因為興趣及專業都不在這方面.

LinkWithin

Related Posts with Thumbnails