March is the spring time and the beginning of everything. The 27^th Quality Month is brewing in YRPG. As you enter the headquarters, you will see a big plaque that reads "Catch up with industrial giants, make excellent products, consolidate quality control and carry out improvement in quality control" in shining characters. These characters are also theme of the 27^th Quality Month, carried out in concrete steps by every member of YRPG.
On April 12, when senior leaders of YRPG signed on the declaration "We will live up to our commitments, keep improving, seek innovative development and pursue excellent quality to ensure that our R&D, procurement of raw and auxiliary materials, production, inspection, sales are in accordance with GMP and GSP standards", they won cheers from the audience. The declaration was a commitment to relentless pursuit of quality, and also onefor this Quality Month.
l        Catching up with International Pharmaceutical Giants in Quality
Early this year, experts from an internationally renowned pharmaceutical company visited YRPG, and had a check of the YRPG's production, quality, safety, environmental protection, professional health and fiscal status. These experts highlighted not only YRPG's achievement, but also gaps between YRPG and its foreign competitors. Leaders of YRPG seized this opportunity and had an overview of YRPG's quality control with its competitors. On the kick-off meeting, the General Engineer gave an in-depth report on the company's current quality control, gaps with itscompetitors and future priorities for improvement. In the meeting, they also set foreign competitors' QC philosophy as their benchmarks, looked for YRPG's own weakness, and further improved its quality control.
On March 21, 800,000 Omeprazole capsules made by YRPG entered German market. It was YRPG's debut in EU marketwhich was known for its stringent control on foreign drugs. The company took this as a start to launch more products to overseas market and consolidate its GMP achievement. It organized a host of quality control activities, which were led by general industrial office and co-hosted by production, command center and QC center. Departments of YRPG hosted symposiums on the existing problems, made adjustments, defined requirements for adjustments, revised codes for many positions and promoted the new codes.
No.1 Freeze-dried Powder Workshop conducted a full-scale review of its workshop, made detailed solution plans and trained staff members. Leaders and technicians contacted relevant departments and discussed improvement and optimization of quality and craftsmanship. Meanwhile, the workshop also encouraged members to offer advice for improvement. As a result, the workshop won the first prize of this quality month.
l        Striving for Higher Standards
Over the past years, YRPG has conducted a series of activities that aimed at better quality, bioequivalence and higher standards for brand drugs. Through years of endeavor, 22 of YRPG's products have met US and UK pharmacopeia standards. With better quality and enhanced competitiveness, YRPG is laying a more solid foundation for its access to overseas market.
During the 12^th Five-year Plan, China will enforce its improvement plan for drug standards to improve quality of generic drugs and improve the state drug standard system with China Pharmacopoeia as its center. In the marking of standards, all chemical and biological pharmaceuticals should meet or get close to international standards; standards for TCM should lead the making of international standards. Generic drugs that were produced prior to the release of2007Regulations of Drug Registering and Management would have to go through the evaluation along with brand drugs in different groups and periods. Evaluation on generic drugs from the list of State Basic Drugs and Common Clinical Drugs should be completed before 2015, and those failed to pass the evaluation could not be registered, and their existing approval documents would be invalid. Generic drugs should be compared with brand drugsas required by 2007Regulations of Drug Registering and Management on a full scale and the results are proof for registration.
It is both a major task of the 12^th Five-year Plan and the key of YRPG's quality objectives to improve drug standards and quality. Therefore, during the 27^th Quality Month, YRPG set up a special working team lead by Xu Jingren. The team, which aimed at ensuring quality of generic products reaching that of brand drugs, dealt with comparative study on quality of unit product of brand drug, made concrete plans, conducted targeted research within the company and reviewed the existing quality evaluation, quality grading, standardization and craftsmanship.
l        Implementing the GMP
The major objective for the 27^th quality month is to accelerate the GMP attestation for new drugs and get all workshops pass the GMP. Through concerted efforts, 4 workshops and 5 preparations have obtained GMP qualifications. Departments and workshops concerned conducted symposiums, made plans, discussed post-quality month work to ensure every staff member grasp and execute the GMP standards. All workshops will follow the standards and make detailed reviews and plans to ensure all of them pass the GMP by the end of 2013.
The company also aimed at following international brands in quality. (Compete with Janssen in solid preparation, Roche in aseptic packaging, SSPC in liquid preparation and Astrazeneca in freeze-dried powder-injection). During the 27^th Quality Month, the production department ordered a double quota for monthly production per person and personal output per unit of time. Accordingly, departments made plans, and conducted labor competition on reducing cost increasing productivity; they optimized the fluorescent inspection; they enhanced labor efficiency through technical innovation and equipment; they have closed the gap with leading competitors. For example, they increased the efficiency by 30% by improving UV florescent inspection, and packing efficiency increased by 20% in No.2 Freeze-dried Powder Workshop through upgrade of its system.
With its concrete steps, YRPG interpreted the nature of quality: the pursuit of quality is perennial, and there's better rather than best, which is echoed by "Every month is quality month to us" by General Manager Assistant Liang Yuantai at the closing meeting of this quality month.