GXP Inspection & Lab Accreditation
【Update Date:2018-10-18】unit:品質監督管理組
Q1: How does the Food and Drug Administration promote GDP for medicinal products?
A: In order to develop a national GDP that is on a par with its international counterparts, the Food and Drug Administration has been promoting the system as an outsourced project since 2011. Through the process, regulations and management mechanisms relevant to GDP were collected from other countries, and international conferences on the GDP of medicinal products were held. In addition, relevant industry briefings, topic forums, technical seminars, and observational visits to logistics companies, among other educational training events, were organized. In addition, between 2012 and 2015, GDP voluntary assistance-oriented visits, 290 rounds in total, were organized for a total of 145 pharmaceutical plants, distributors, dealers, and transporters. Experts went on-site to provide guidance on GDP hardware, technical, and management requirements, and to exchange opinions with businesses taking advantage of such site visits. From 2016 to the present, educational training events have continued to be made available for businesses, such as briefing sessions, topic forums, and assistance-oriented visits, among others. These have helped businesses apply GDP regulations to their actual operations.
Q2: What businesses are required to carry out GDP?
A: In the present Stage 1, businesses that need to implement GDP include Western Pharmaceutical Manufacturers for pharmaceutical products (including those producing medicinal gases); logistics companies that deal with labeling and packaging of medicinal products; and drug dealers holding drug permit licenses for pharmaceutical products, among others.
Q3: What are the legal bases for which businesses are expected to be implementing GDP during Stage 2?
A:With regard to business undertakings engaged in wholesaling, importing and exporting western pharmaceuticals that are required to meet GDP requirements, the competent authority has already revised the Pharmaceutical Affairs Act. Article 53-1 was added to the Pharmaceutical Affairs Act and announced as taking effect through a presidential order dated June 14, 2017; the contents of said article are as follows:
Business undertakings engaged in wholesaling, importing and exporting pharmaceuticals, their product procuring, holding, supplying related to the quality management, organization and personnel, premises and equipment, documentation, operation procedures, customer complaints, returns and recalls, outsourced activities, self-inspections, transportation and other pharmaceuticals distribution practice, shall meet the standard of Western Pharmaceuticals Good Distribution Practice Regulations, and shall obtain the western pharmaceuticals distribution license upon the inspection and approval from the central competent health authority.
The contents from previous paragraph shall be enforced in several phases. The enforcements of pharmaceuticals and the types of pharmaceutical firms, requirement, methods and schedules shall be announced by the central competent health authority.
Business undertakings who meet the standard of paragraph 1 obtaining the western pharmaceuticals distribution license, may pay the corresponding application fees to apply for certificates with the central competent health authority.
Western Pharmaceuticals Good Distribution Practice Regulations and western pharmaceuticals distribution license of paragraph 1, the application requirements, review procedures and criteria, approval and issuance, validity period, revocation, return and cancellation of the license of the previous paragraph and other matters requiring compliance shall be prescribed by the central competent health authority.
In addition, in response to the GDP implementation indicated in Article 53-1, penalties for violating the GDP were added. The revised Article 92 of the Pharmaceutical Affairs Act stipulates that any violator shall be issued a fine, and that the central competent health authority may publicly announce the name of the medicament factory or pharmaceutical firm and order them to make rectification within a prescribed time period, and during the time period for such rectification, may suspend, in whole or in part, their manufacturing, wholesaling, import, export, and business operations. If rectification is not made within the prescribed time period, the competent health authority may deny approval for extension of the validity of the medicament permit license previously granted, and will not process any other new application for other medicaments from the given factory or firm; in the case of severe violation, the competent health authority may revoke all or part of the medicaments manufacture license.
Q4: For drug dealers who do not hold a western pharmaceutical product permit license , by what time should they meet GDP requirements?
A: Drug dealers of medicinal products are responsible for ensuring the quality and integrity of the medicinal products, and for preventing such products from going bad during the wholesale, storage, and transport process, in order to protect the medication safety of the public. The government is promoting GDP for medicinal products in separate stages. First, the government is providing businesses with education and assistance. In the future, further announcements will be made so that all pharmaceutical distributors meet GDP requirements.
Q5: Is implementation of GDP required for transporters?
A: While medicinal products are being transported, their quality and integrity are to be ensured. Although it is not required for a transporter to have a western pharmaceuticals distribution license, GDP requirements still need to be fulfilled, and the client (the drug dealers) is responsible for ensuring their compliance with GDP requirements.
Q6: Are businesses holding an export-only license included in the Stage 1 GDP inspection?
A: Article 3 of the Pharmaceutical Good Manufacturing Practice Regulations stipulates that the manufacturing, processing, re-packaging, packaging, storage, and distribution of western medicinal products, including those only for export, shall comply with good manufacturing practices for Western medicinal products adopted by the competent central health authority with reference to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Thus, pharmaceutical companies holding an export-only license are to be inspected during Stage 1 and hence shall submit their GDP inspection requests as scheduled.
Q7: Are businesses that only manufacture or import medications for use in clinical trials included in the Stage 1 GDP inspections?
A: For the current stage, implementation is prioritized for pharmaceutical companies holding a drug permit license; businesses that only manufacture or import medications for use in clinical trials are currently not included.
Q8: Do retailers (such as convenience stores/grocery stores, etc.) holding a Pharmaceutical Dealers business permit license and the pharmacy departments of hospitals and pharmacies need to follow the Western Pharmaceuticals Good Manufacturing Practice (Part III: Distribution) and receive inspections?
A: The Western Pharmaceuticals Good Manufacturing Practice (Part III: Distribution) applies to wholesalers of medicinal products that are engaged in all procurement, storage, supply, importation, and exportation activities; however, this does not include supply of medicinal products to the general public. Retailers, nevertheless, shall still protect and ensure the quality and integrity of medicinal products during storage and distribution.
The storage of medicinal products in the pharmacy departments of hospitals and pharmacies is already specified in the Good Dispensing Practice. There are also relevant assessments specified in the Hospital Accreditation Standards. Requirements in the Western Pharmaceuticals Good Manufacturing Practice (Part III: Distribution) do not apply.
Q9: GDP Implementation Timetable
A:(1) Starting July 1, 2016, the following businesses shall begin implementing GDP: Western Pharmaceutical Manufacturer that are newly established, relocated, and reinstated; logistics companies dealing with labeling and packaging of pharmaceuticals; and distributors applying for the first drug permit license shall meet GDP requirements when applying for Good Manufacturing Practice (GMP) inspections.
(1) Prior to December 31, 2018, the following businesses shall finish implementing GDP: Existing Western Pharmaceutical Manufacturer; logistics companies that deal with labeling and packaging of pharmaceuticals; and drug dealers holding drug permit licenses.
Q10: Is filing for reference required if medicinal products are stored off the registered site of the pharmaceutical company or outsourced for storage?
A: As is required by the Enforcement Rules of the Pharmaceutical Affairs Act, the Pharmaceutical business permit license (remarks field) must show the site of the warehouse where medicinal products are actually stored. If medicinal products are stored at a self-owned warehouse off the registered site of the pharmaceutical company, at a rented warehouse, or at the logistics company’s location, registration of alteration shall be autonomously applied for with the local municipal or county (county-level city) competent health authority.
Q11: If implementation of GDP is not completed before December 31, 2018, what will happen?
A: The Ministry of Health and Welfare announced on July 16, 2015 and February 18, 2016 the Western Pharmaceuticals Good Manufacturing Practice (Part III: Distribution) (GDP), and the GDP implementation items and schedule (with businesses indicated in the subject field to meet GDP requirements starting on January 1, 2019); and announced the addition of Article 53-1 of the Pharmaceutical Affairs Act and the Western Pharmaceuticals Good Distribution Practice Regulations on June 14, 2017 and December 28, 2017, respectively.
Effective January 1, 2019, all Western Pharmaceutical Manufacturers and drug dealers holding western pharmaceutical products permit license are to accomplish across-the-board implementation of the PIC/S GDP. Those not meeting or failing to complete GDP authorization as required by then may not engage in the distribution of medicinal products. Businesses may continue making improvements in accordance with the applicable requirements; only after GDP inspection has been performed, and a western pharmaceuticals distribution license has been obtained, may distribution resume. The local government Department of Health will verify if respective operations meet requirements from time to time.
Q12: Do holders of import western pharmaceutical product permit licenses who do not actually import/distribute medicinal products on their own, or who do not have medicinal products stored inside their company and who outsource all medicinal products to a GMP pharmaceutical manufacturer or a logistics company, also have to apply for GDP compliance?
A: Yes. License holders are responsible for the safety, quality, and recall of medicinal products. Businesses must establish their quality system and documentation, including the SMF, Quality Manual, and relevant SOPs (quality management, personnel, documentation, operations, outsourced activities, product complaints, return, recall, suspected falsified medicine management, self-inspections, etc.) and sign contracts with authorized distributors that specify the scopes of responsibility of the parties.
Q13: Do pharmaceutical manufacturers that sell entire batches of medicinal products to distributors also have to apply for GDP compliance?
A: Yes. Pharmaceutical manufacturers should establish the SMF, Quality Manual, and relevant SOPs (quality management, personnel, documentation, operations, outsourced activities, product complaints, return, recall, suspected falsified medicinal product management, self-inspections, etc.), and need to create relevant SOPs for approving customers (to whom medicinal products are supplied); that is, medicinal products may only be supplied to recipients meeting national regulatory requirements, with relevant distribution records available, and should sign contracts with authorized distributors that specify the scopes of responsibility of the parties.
Q14: Do GDP-related SOPs and SMFs, among others, have to be in Chinese?
A: Related GDP ducuments must be in Chinese or bilingual (Chinese and foreign language).
Q15: For a foreign company that sets up a branch office in Taiwan, can the relevant documents and SOPs be written in English?
A: GDP documents should be sufficiently readable and understandable for the users in order for them to understand the quality system of the company. When necessary, consideration should be given to suitable local internalization and implementation of quality documents, in order to ensure the applicability and effectiveness of the quality system. Therefore, such documents should still primarily be in Chinese or bilingual (Chinese and English).
Q16: If the data required as per GDP review feedback are scattered in several SOPs, can the reply be provided in form of a clarification letter, without the need to prepare a separate SOP?
A: In order to ensure that an appropriate management system is in place for the business concerned, it is still required that the business provide relevant documents for review. If requirements in review feedback involve content from several SOPs, such documents may be submitted at the same time and noted; there is no need to prepare a separate SOP in addition to the review feedback.
Q17: If GDP operations and relevant items are changed, how should the application is submitted? What materials are to be enclosed?
A: For changes to the name of the pharmaceutical company, registered address of the pharmaceutical company, or change in managing pharmacist, Article 27 of the Pharmaceutical Affairs Act and Articles 9 and 10 of the Enforcement Rules shall be followed while the change to the Pharmaceutical business permit license is applied for with the local Department of Health; and the change to the approved scope of operations for GDP is to be filed with the TFDA within one month following said change. As for changes to originally approved GDP operations (procurement, storage, supply, importation, exportation, and transportation) or the storage site for medicinal products, requests for GDP inspections shall be re-submitted to the TFDA; relevant operations may only begin following approval by the TFDA.