Medical Rubber Stopper Production Quality Administrative Regulations (GMP) and other 4 other association standards were approved recently. The annual meeting of the Rubber Stopper Special Committee of China National Pharmaceutical Packaging Association (CNPPA) was held on March 13th in Shijiazhuang. The theme of this annual meeting was to audit and approve 5 association standards. Nearly 60 representatives from over 30 companies attended the meeting.
The packages of medical rubber stoppers and other direct contact medicines are as important as the safety of the drugs. Their management requirements should be subject to the drugs’. This idea has been broadly identified in the industry. Currently, many drug production companies are implementing the newly compiled drug GMP certificate. Medical packaging materials’ quality and safe application are getting more and more attention from management levels, the medical industry and medical packaging material. Medical packaging material GMP and other industry standards were drafted and drawn up in such background. Experts in the industry pointed out, the new association standards have important meanings for company standardized production and drug packaging industry upgrade. They lay a solid foundation for the future GMP certificate implementation in rubber stopper production companies. At the same time, they will help to enhance rubber stopper product quality, standardize industrial development and improve the companies’ market responding abilities.
The 4 other association standards that were also approved were: medical rubber stopper supplier quality audit implementation guidelines, medical rubber stopper material balance audit guidelines, medical rubber stopper synthetic polyisoprene rubber standards, medical rubber stopper synthetic polyisobutylene rubber standards.
It is understood that these 5 standards were all drafted by leading companies in the industry. There went through multiple modifications in three years to become the documents now. At the end of August in 2013, CNPPA officially put them online for comments. For half a year, companies in the industry have proposed some modification comments and suggestions. The Association’s Rubber Stopper Special Committee has discussed with the standards’ relevant drafting units. They studied them clause by clause. Modified some, and explained and responded to some. As the executive director unit of this Rubber Stopper Special Committee, Hebei First Rubber Medical Technology Co., Ltd. actively communicated and coordinated, effectively promoting the association standards to be approved as scheduled.
The value of the standards is their implementation. Therefore, how to implement the 5 approved standards became an important agenda of this annual meeting. The attending representatives were mostly company managers and technicians. From their speeches, they all thought the 5 standards are advanced and practical. Leading companies in the industry should implement them first. Parts of the standards involve drug authorities and down-stream drug manufacturers. It is expected that they will cooperate. The industry should create a survival mechanism. Companies that dare to invest in quality management will get positive returns. By no mean that the pioneer companies of the standards will become “martyrs”.
“Association standards should be a banner.” was how the vice president and secretary general of CNPPA, Cai Hongru positioned the association standards. “Making association standards is to lead industry direction, provide suitable company implementation norms, tell the companies to at least do what, and at the same time, provide our users with scientific references for choosing excellent suppliers and high quality products. Implementing association standards is mainly dependent on the companies’ self discipline.”
Jiangsu Hualan New Pharmaceutical Material Co., Ltd. is a drafting unit of the medical rubber stopper GMP. Its chairman Hua Guoping pointed out one or two good companies is not good. The whole industry being strong is really good. The association should create good norms, so the member companies will all implement them following the standards. Association standards getting approved is only the first step of the Long March. Improving and implementing them in the future is still a long way to go. Leading standard implementation is the companies’ social responsibility. He suggested the association should strengthen the standards’ publicity. Should especially let the drug production companies understand the efforts that rubber stopper companies are putting in.
This annual meeting also elected the Rubber Stopper Special Committee’s Technical Expert Group through negotiation.