Full compliance with the PIC/S GMP Guide is required for all licensed pharmaceutical manufacturers (with effect from 1 October 2015)
On 17 October 2014, the Drug Office of the Department of Health, the Government of Hong Kong Special Administrative Region briefed licensed pharmaceutical manufacturers on the new licensing condition. It is confirmed that a full compliance with the PIC/S GMP Guide is required for all licensed pharmaceutical manufacturers, with effect from 1 October 2015. The Hong Kong Guide to GMP for the Secondary Packaging applies to any company carrying out the secondary packaging of pharmaceutical products in Hong Kong.
Secondary packaging operations involving the application of a supplementary label that does not obliterate, change nor display information relating to the original name, list of ingredients, dosage instructions, batch number or expiry date of the pharmaceutical products are exempted from the requirements of the Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products.
What is Secondary Packaging?
A manufacturing step involving the labelling, re-labelling, cartoning, re-cartoning or adding additional information (including inserts) to pharmaceutical products which are already enclosed in the container in which they are to be sold or supplied.
Who is Secondary Packager?
Any parties in the supply chain of pharmaceutical product(s), apart from the manufacturers themselves, involving in secondary packaging are considered to be Secondary Packager. It basically included: Distributor of Pharmaceutical Products; Pharmaceuticals Enterprise who owned the warehouse or provide their own distribution; and Logistics Service Supplier Involved Medicinal Products.
What SGS can help?
We could offer intensive training course for parties intended to acquire PIC/S GMP knowledge for secondary packaging. This intensive course aimed to addresses the latest PIC/S GMP requirements specifically for secondary packager who provides services like repackaging & relabeling processes of pharmaceutical products.
The contents and the discussions will help each individual involved in manufacturing put the PIC/S GMP requirements into practice. The situations and experiences shared will help participants to find solutions to common problems in PIC/S GMP. The point of view as an auditor will enhance individuals to identify areas for improvement for their operations while enhancing a positive attitude towards PIC/S GMP.