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Key Points about How MasterControl can Help Pharmaceutical Companies Become Compliant with PIC/S

PIC/S is the acronym used to describe two groups operating in parallel in the GMP (Good Manufacturing Practice) field: the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme). The PIC Scheme is a cooperative arrangement between the health authorities of various nations that seeks to continue and enhance the work of PIC, which is a formal treaty and has legal status. With PIC/S standards now applicable to Japanese markets, pharmaceutical companies are turning to electronic quality management solutions like MasterControl to achieve compliance.


About PIC and PIC/S

The PIC was founded in 1970 by the European Free Trade Association under the title of “The Convention for the Mutual Recognition of Inspection in Respect of the Manufacture of Pharmaceutical Products.” Originally comprised of the 10 EFTA members at that time, it became clear in the 1990s that it would not be possible to admit new countries as members due to the incompatibility of the Convention and European law. So a flexible and less formal cooperative plan was devised to function between the health authorities of different nations rather than the countries themselves.


The PIC and the PIC Scheme, now operating together as PIC/S, was created to provide active and constructive cooperation in the field of GMP. As two entities acting in tandem, PIC/S facilitates networking between participating authorities, the exchange of GMP and GMP-related information and experience, and the mutual training of GMP inspectors. With a goal to help develop and promote harmonized GMP standards and guidance documents, PIC/S continues to lead the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates in the field of medicinal products. As of July 1, 2014, the PIC/S GMP standards are applicable to the Japanese pharmaceutical market.


The Purpose of the PIC Scheme

According to the PIC/S website, the role of the PIC Scheme in regards to public health is:

  • to pursue and strengthen the cooperation established between the participating authorities in the field of inspection and related areas with a view to maintaining the mutual confidence and promoting quality assurance of inspections,
  • to provide the framework for all necessary exchange of information and experience,
  • to coordinate mutual training for inspectors and for other technical experts in related fields,
  • to continue common efforts towards the improvement and harmonization of technical standards and procedures regarding the inspection of the manufacture of medicinal products and the testing of medicinal products by official control laboratories,
  • to continue common efforts for the development, harmonization and maintenance of Good Manufacturing Practice (GMP), and
  • to extend the cooperation to other competent authorities having the national arrangements necessary to apply equivalent standards and procedures with a view to contributing to global harmonization.


To see a list of the national authorities that participate in the PIC Scheme, visit the PIC/S website. Note that Japan’s Ministry of Health, Labour and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) count as one PIC/S participating authority and the Japanese prefectures are represented by MHLW.

Changes to the PIC Scheme

A new, major reorganization of the PIC Scheme structure went into effect on January 1, 2014 in response to the growing membership of PIC/S. The restructuring is intended to provide a more participatory and efficient organization for all 44 PIC/S participating authorities through the creation of Sub-Committees. According to the PIC/S website, “each Sub-Committee is responsible for its respective core areas of competence and takes the lead in developing policies.” You can view the new PIC/S organizational chart and the composition of the Executive Bureau that steers the Sub-Committees here.

How Does PIC/S Regulation Apply to Japan?

The PIC/S GMP are new to Japan as of July 1, 2014. They are similar to Part 210/211 and the EU GMP, but fill in some gaps to the GMP standards that typically apply to Japan. According to the Pharmaceuticals and Medical Devices Agency (PMDA), there are six key factors in PIC/S that pharmaceutical companies in Japan need to be aware of:

  • Risk management
  • Annual Review
  • Sample product management
  • Safety monitoring of product/APIs
  • Supplier management
  • Validation


How MasterControl Facilitates Compliance with PIC/S

To be compliant with the new PIC/S standards applicable to the Japanese market, pharmaceutical companies will need a quality management system (QMS) that allows them to effectively meet the requirements of the GMP. MasterControl QMS software solutions have a proven track record of helping pharmaceutical companies maintain compliance with GMP standards such as those outlined by PIC/S. Here are just a few of the ways that MasterControl can help companies achieve and sustain compliance with PIC/S GMP guidelines:

  • Total Quality Management: Pharmaceutical companies need a quality management system that can provide complete information management across the entire enterprise. Not only are MasterControl software solutions easy to implement and use, but they are specifically designed to securely manage critical information throughout the entire lifecycle of a product. MasterControl is a holistic QMS that unites all aspects of quality management—document control, training management, CAPA, and so forth—in order to allow pharmaceutical companies to maintain compliance, reduce overall costs, and increase internal efficiency.
  • Effective Risk Management: MasterControl has tailored its integrated risk management software solution to help pharmaceutical companies identify and mitigate long term systemic risks by tracking and analyzing the recurrence of issues. The system ensures that internal risk thresholds are followed and provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units whilst helping companies avoid reputation damage from recalls or regulatory action.
  • Centralized and Accessible Supplier Management: The secure yet easy to access MasterControl repository contains all supplier statuses and quality information (such as nonconforming material reports) for retrieval by authorized users. By electronically managing and monitoring the information on an approved vendor list (AVL), supplier quality ratings can be easily compiled and all documentation and records related to each supplier can be accessed without any difficulty. The MasterControl system also gives users the ability to add goods and services to an “approved to supply” list by simply linking them to a specific supplier.
  • Accurate and Meticulous Audit and Annual Review Management: To ensure regulatory compliance and improve product quality and safety, regular quality audits and/or annual reviews are a requirement for any pharmaceutical company. MasterControl enables efficient execution of audits and reviews, streamlines the capture and management of findings and responses, facilitates the effective planning and scheduling of audits and resources, and simplifies the reporting on the resulting data. MasterControl effectively manages the entire audit process from beginning to end and ensures that issues raised during audits and reviews can be properly addressed. Crucial information from reviews and audit observations is automatically captured and entered into appropriate action forms (e.g., CAPA, SCAR, Issue Review, etc.). The MasterControl system also serves as a workspace that allows teams to efficiently manage information such as audit type, date, summary, scope, conclusion, observations, etc.
  • Easy and Effective Validation: MasterControl solutions are world renowned for being easy to validate. MasterControl eases the burden and reduces the time of validation by making it a part of change control, which means validation is more likely to remain focused on verifying that the change meets the user’s requirements and less likely to experience the scope creep often associated with validating software.

For More Information about MasterControl

To learn more about the benefits of MasterControl’s electronic eQMS, contact us or call 03-5422-6662.