Consulting Service for Implementation of GMP PIC/S Standards

PIC/S, the Pharmaceutical Inspection Co-operation Scheme, is an international organization dedicated to harmonizing drug manufacturing standards. Through collaboration between GMP inspection bodies and European government agencies, PIC/S has established rigorous GMP PIC/S standards to ensure consistent manufacturing practices and stringent quality control. These standards cover all aspects of the production process, including raw materials, machinery, methods, storage, and distribution.

The PIC/S organization conducts inspections mainly using GMP standards, aiming to ensure that manufacturers produce products with consistent standards and are confident in their safety before sending them to consumers. It focuses on inspecting manufacturers of pharmaceuticals, food supplements, and cosmetics. Currently, there are more than 40 PIC/S member countries around the world. For Thailand, the Food and Drug Administration (FDA) was officially recognized as the 49th member of PIC/S (Pharmaceutical Inspection Co-operation Scheme) on August 1, 2016.

GMP-PIC/S Standards: Superior to GMP Standards

The GMP PIC/S standard is more stringent than the general GMP standard. With stricter requirements and a larger number of regulations, there are 217 more regulations and 240 more additional regulations than the GMP (Good Manufacturing Practice) standard, which has only 77 regulations. To reduce the risk of product contamination under working conditions that are clean, safe, and free from bacteria, such as using grade 316L pipes in the water system to prevent rust, HVAC air conditioning systems, clean room production room design, etc. Manufacturers can be sure that their products will be of consistent quality. Consumers can also be confident that the products on the market are of high quality and traceable.

The standards are strict, rigorous, and comprehensive, and differ from GMP-WHO. Therefore, developing a GMP-PIC/S system is considered to be an upgrade of the drug manufacturing standard and development of personnel potential to be comparable to the standards of the European Union (EU-GMP).

GMP PIC/S in the Health and Beauty Industry

Consumers always choose what has the best quality and benefits for themselves. For factories in the health and beauty industry to be considered a qualified pharmaceutical factory and to be able to ensure that the products they produce are safe and of the quality registered, they must be produced under GMP PIC/S standards. It can be assured that the production efficiency will be of higher quality and safety standards. However, entrepreneurs also have to bear the investment costs to prepare for certification for additional standards. Obtaining this certification will give consumers confidence that they will receive products that are of high quality, performance, and safety, in accordance with the standard requirements, comparable to the quality standards produced from abroad.

Industries We Consult and Implement GMP-PIC/S Standards

The GMP PIC/S standard is suitable for use in industries that require high standards and maintain production standards for safety, covering the health and beauty industries that we provide consulting services for, as follows:

• Pharmaceutical industry
• Food supplement industry
• Cosmetic industry
• Medical device industry
• Veterinary drug industry
• Herbal medicine industry

Who Should Implement GMP-PIC/S Standards?

• Organizations that want to build confidence in their work performance and production safety
• Businesses/organizations that want to build confidence for business expansion plans
• Organizations looking for opportunities to enter new markets
• Businesses/organizations that want to build confidence in the quality and safety of their partners
• Factories that want to be certified for quality assurance systems under legal requirements and regulations

Benefits of Implementing GMP-PIC/S Standards in Organizations

• Enhanced work performance and production safety
• Increased confidence for business expansion plans
• Access to new markets
• Increased confidence in quality and safety for partners
• Compliance with legal requirements and regulations

Our GMP PIC/S Consulting and Implementation Services

TIBD provides GMP PIC/S consulting services to develop your organization, operated by a team of consultants with expertise and experience in system implementation, assessment, and training for over 20 years. Our services include:

• GMP PIC/S system consulting services
• Preparation of documents for certification application
• Application for certification of the standard system
• Internal monitoring by experts before the actual certification inspection
• Correction of defects after certification to ensure that you will receive certification for sure

Contact Us

Ready for GMP PIC/S compliance? Elevate your manufacturing standards with TIBD’s implementation consulting. Ensure product safety and unlock global market access. Plan and schedule your consultation with us today.

Should you seek detailed insights or wish to discuss the advantages of implementing GMP PIC/S, TIBD is at your service for expert consultation. We also welcome personal engagements at our Bangkok headquarters. Please convey your interest through the contact form below, and a representative of TIBD will ensure a prompt and professional response.