Good Manufacturing Practice certificate for local manufacturers

Overview

Good Manufacturing Practice (GMP) certification is a voluntary scheme offered to local manufacturers of the following products, interested to be certified for conformity with relevant GMP standards by us:

• Therapeutic products
• Chinese proprietary medicine
• Active pharmaceutical ingredients
• Cosmetic products
• Medicated oils and balms

To apply for a GMP certificate, you must be authorised by your company to do so as the person responsible, such as managing director, QA/QC manager or production manager.

GMP certification audit

After our GMP auditors have completed the GMP certification audit and find that your company has demonstrated satisfactory compliance with the required GMP standard, we will issue the certificate in the name of your company as registered with the Accounting and Corporate Regulatory Authority. The scope of certification is normally determined by the scope of the actual audit that was performed at the manufacturing facility and the types of dosage forms or range of products being manufactured.

A GMP certificate is valid for three years from the date of assessment and cannot be renewed or amended. Upon expiry, you will need to submit a new application if you are still interested in re-certification. GMP audits will apply.

Documents required

A Site Master File must be attached in the application. For information on the preparation of a Site Master File, refer to the relevant guidance notes:

• Guidance Notes for Pharmaceutical Manufacturers on Preparation of a Site Master File (for therapeutic products, chinese proprietary medicine, active pharmaceutical ingredients)
• Guidance Notes on Preparation of a Site Master File for Manufacturer of Cosmetic Products235 KB (for cosmetic products)