GXP Inspection & Lab Accreditation
【Update Date:2018-10-18】unit:品質監督管理組
Q1: For PMF application dossiers, how to meet Regulations of Medicament Manufacturer Inspection, Article 5, Paragraph 2 regarding legalization?
A1: The applicant may choose one of the following for submission:
l PMF or SMF, which is to be certified by the highest competent health authority or the chamber of commerce in the country of origin or legalized by the embassy, representative office or agencies authorized by the Ministry of Foreign Affairs of R.O.C.
l Original copy or original certified photocopy of the Certificate of Compliance with the local Good Manufacturing Practice issued by the highest competent health authority in the country of origin (if the two original documents mentioned above were already submitted to the TFDA through other cases, a photocopy of the whole document may be enclosed, with indication of the case number where the original copies were submitted to the TFDA)
l Original copy or original certified photocopy of the Certificate of Pharmaceutical Product manufactured in compliance with the local Good Manufacturing Practice issued by the highest competent health authority in the country of origin (if the two original documents mentioned above were already submitted to the TFDA through other cases, a photocopy of the whole document may be enclosed, with indication of the case number where the original copies were submitted to the TFDA)
l If the paper based or electrical based GMP certification is no longer available in the country of origin, the original Certificate of Pharmaceutical Product issued by any one of the 10 reference countries, which include Germany, US, UK, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden or the CPP issued by the EMA (European Medicine’s Agency), or by the highest competent health authority in the country where the contractor is located may be enclosed in accordance with the letter TFDA Risk No. 1051105400 dated October 17, 2016
Q2: Can simplified PMF Application be applied for with non-sterile products, sterile products, and biological medicinal products manufactured by the company in the members states of PIC/S?
A2: Yes. In addition to submitting the documents according to the Information on Preparing for PMF Application, the simplified approach means enclosure of the list of GMP inspections conducted by the local competent health authority within the last five years, and the inspection report and corrective and preventive actions for the most recent GMP inspection conducted by the local health competent authority.
Q3: Please explain the principles of PMF review for foreign pharmaceutical companies which manufacture both human drug and animal drug.
A3: According to Article 5 of the Standards for Medicament Factory Establishments, Facilities and equipment used to manufacture medicinal products for humans and animals should be kept separately. Separate areas should be designated for manufacturing medicinal products for humans and animals, unless those for animals meet the manufacturing specification for humans (for example, included in Pharmacopoeia).
Q4: Please explain the principles of PMF review for foreign pharmaceutical companies which also manufacture non-medicinal products (e.g. medical devices, food, cosmetics).
A4: The manufacturer must clarify the status and describe in detail about non medicinal products (e.g. medical devices, food, cosmetics) manufactured in shared facilities and equipment which is also used for the dosage form/manufacturing process/biological products related to their PMF application and also enclosure the preventing measures of cross-contamination.
Q5: What is the PMF application form for a secondary packaging company?
A5: For those company performing secondary packaging only, regardless of whether non-sterile, sterile, or biological products are involved, the application follows that for non-sterile products with regard to documents to be submitted for review. The applicant must fill in the column “Type of Application” in Form A.
Q6: What is the average duration of review for a PMF application at the moment?