For Process Validation & Microbial Control For Sterile

 

INTERNATIONAL WORKSHOP
For Process Validation & Microbial Control For Sterile
Pharmaceutical Products
(This workshop is available to on-site and on-line options）
Organizer: NovoScience Consulting Co., Ltd
Date：Nov. 27-28, 2014 Location：Shanghai, China
------------------------------------ Our Speakers --------------------------------
 

 

 

There are numerous sterile pharmaceutical product manufacturers in China. Safety, efficacy and steady quality are the general requirements for pharmaceutical product. For approved sterile pharmaceutical products, the primary feature of those requirements is to establish and maintain
sufficient sterility control. According to collected statistics from US FDA, adverse effects in sterile products majorly were induced by aseptic processing product. Most recently, FDA issued a warning letter to GSK Biologicals located in Quebec, Canada, which indicated that
deviations and non‐compliance from cGMP are observed. Those observations included: (1) GSK failed to establish and follow the procedure that prevents the microbial contamination to assure the sterility of the product, and it was observed that the average
endotoxin in the 20 lots of seasonal vaccine lots in 2012 was higher than the trends in 2010
and 2011, but the such OOT was believed as a atypical problem after investigation. (2)
Controls for the purified water system at the facilities were inadequate to prevent bioburden
and endotoxin excursions. (3) Manufacturing controls on site for the process were
inadequate to control bio‐burden and endotoxin. Throughout 2013‐2014, the process
continued to generate Out of Specification (OOS) results on bio‐burden and endotoxin even
after several corrective action and preventive actions (CAPA) were implemented.
After the official issue of the new Chinese GMP, manufacturing facilities adapted for sterile
pharmaceutical products are generally improved among domestic pharmaceuticals. Widely
installed isolators and RABS system are involved in those sterile filling lines. However,
the sterility test is very risky because of limited sampling, and thus process validation
(including media filling) and microbial control shall be adapted even with advanced
manufacturing facilities. In this case, sterility of sterile pharmaceutical products can be only
guaranteed by close combination of hardware system and software system. Modern quality
management approach, which presents concept of science--‐based (advanced facilities
and scientific proofed process) and risk--‐based (risk assessment among process validation
and microbial control), is required for current sterile product manufacturing to guarantee
the product safety, efficacy and steady quality. At present, national and international
government organization or regulatory authorities and its regulations, namely FDA‐cGMP,
EU‐GMP, Chinese GMP, WHO‐GMP, PIC/S‐GMP and ICH, and those participant countries
involved now acknowledge that enforcement of the science‐based and risk‐based is critical to
sterile production process.
Although most of sterile product manufacturers are focus on China domestic market, there
are still a few pharmaceutical companies attempt to register their product into high‐end
market in the US or Europe. Hence, the improvement on quality assurance for high‐risk
sterile products will not only guarantee the domestic patient safety in China market, but also
assure the safety of overseas patients, especially for US and EU markets, which the
regulation and concerns on adverse reactions are much more strict. Only the cost advantage is
not enough for Chinese sterile pharmaceutical products access to US/EU markets, but also
shall have reliable and steady sterility quality assurance. The international workshop will
understand how to execute the “Science‐based and Risk‐based” pharmaceutical quality
management principles via the training and interpretation on process validation for sterile
products and microbiological control from overseas senior experts.
The international workshop will be held in Shanghai on 27‐28 Nov 2014, regulatory officer,
domestic and multi‐national pharmaceuticals representatives including product manufacturing,
process validation, quality assurance, quality control (microbial lab), R&D (Qbd), etc
supervisor and staffs are welcome to attend this program.

 

  

 

 

Fee Type
Registration Fee	Standard registration fee: RMB￥2,800/person, discount may be available if one of condition hereafter meets: 1. For one place registered at a full price, another place would be exempted from registration fee. Two additional free on-site training places with one online training account would be provided if two places have been registered at a full price. 2. Current consulting clients of NovoScience (having contract within its effective dates) can enjoy 80% discount. 3. State/local regulation authorities would obtain special discount, please contact the organizer for further information.
Online Training	Trainees would be able to watching the on-site training lectures and discussion through the GOTOMEETING training platform (click here to access the GOTOMEETING training platform). The interaction between online trainees and experts would intercut. The registration fee would the following: 1. Where two and more people are registered on-site in full, the on-line training account would be free for the registered company. 2. RMB￥2,800/company or RMB￥1,500/course for companies who participate only our on-line training.