The NPRA, Malaysia has recently published a guidance note on setting up a manufacturing facility for for cell and gene therapy products (CGTPs).
About the guidance note
The 12 page guidance note facilitates and provides guidance for organisations or establishments wishing to setting up a manufacturing facility for CGTPs which are regulated by NPRA. The guidance document contains the regulatory process description and type of inspection involved for CGTPs manufacturing facility as well as frequently asked questions (FAQs).
Which CGTPs are in scope of the guidance?
The scope of the guidance note is only applicable to Class II CGTPs: Higher risk cell therapy products.
Which CGTPS are out of scope of the guidance?
The guidance note excludes Class I CGTPs: Lower risk cell therapy products since this class of CGTPs is not regulated by NPRA.
Under what headings is the information in the guidance note provided?
The information is provided under the following headings:
- 3.0 GUIDELINES IN USE – Applicants must be fully aware and understand the legal requirements and guidelines used in initiating the set-up of a CGTPs manufacturing facility in Malaysia, so a list of the relevant guidelines is provided.
- 4.0 REGULATORY PROCESS DESCRIPTION
- 4.1 Facility Layout Submission
- 4.2 Preparation of Pharmaceutical Quality System (PQS)
- 4.3 Inspections
- 5.0 DEPARTMENT IN-CHARGE
- 6.0 OTHERS
- 7.0 ABBREVIATIONS
- 8.0 FREQUENTLY ASKED QUESTIONS (FAQs)
Source: NPRA website