Lectures on Pharmacy Legislation (Lec 03)

Lecture 3 started on 30 April and it separated into two sections. The first one was “Manufacture of Pharmaceutical Products” and the second one was “Registration of Pharmaceutical Products & Substances”.


The definition of Manufacture was shown as follows:
- Preparation of pharmaceutical products for sale or distribution but shall NOT include the individual dispensing on a prescription or otherwise or any Pharmaceutical Products
- Repackaging for sale or supply falls within the limit of the definition of “Manufacture”

There were 40 holders of a manufacturer’s license in Hong Kong at the end of 2009. They were:
- 25 Certified GMP Manufacturers (Only 3 to manufacture sterile preparations)
- 12 Contract-out Manufacturers
- 6 Vet. Pharmaceutical Product Manufacturers.

Application for Manufacturer License(s) should include the following information:
* Site Master File
- Name and address of the applicant
- Activities related
- Premises (Model and Capacity of the equipment and facilities, as well as, floor-plan)
- Qualifications of Key Personnel
- Records

Key Personnel Structure and their qualification requirement were shown below.
i) Quality Assurance / Authorized Person
Authorized Person (AP) should be HK Registered Pharmacist with at least 3 year of relevant GMP pharmaceutical manufacturing / quality control experience.
ii) Quality Control & Production
The head of Production & QC should at least have:
- BSc in relevant science subject with at least 3 years of relevant GMP pharmaceutical manufacturing / quality control experience; or
- HD in Pharmaceutical Technology, or with at least 3 years of relevant GMP pharmaceutical manufacturing / quality control experience; or
- Certificate in Dispensing Studies with at least 2 years of relevant GMP pharmaceutical manufacturing / quality control experience

Health and Hygiene of workers required to avoid contamination of productions as follows:
- Medical Examination & History records
- Report of sickness or injury
- Protective clothing
- Provision of isolated eating, smoking and rest areas
- Training and education of technical staffs and employees

Premises for manufacturing requirement for fittings and machinery included:
- Permit Ready and Efficient Cleaning of all surfaces
- Premises in a Clean and Orderly condition
- Controlled Temperature and Humidity
- Separate Aseptic Area for Parenteral Products

Quality Control included:
- Testing of each batch of raw material to ensure identity and purity
- Testing of each batch of finished product to ensure identity and potency
- Parenteral Products in accordance with British Pharmacopoeia or other Pharmacopoeia
- Control sample kept for not less than normal shelf life or 2 years after the last transaction
- Recall System

Labeling of products and maintenance of records were also required.

The history of Hong Kong GMP was briefed as follow. A working party on GMP for manufacturers formed in 1993. Then HK GMP Guidelines for Pharmaceutical Products was published in 1995. The implementation schedule showed:
Phase I To be completed before 31 Dec 1996 (Documentation Phase)
Phase II (SOP in place)
IIa (31 Dec 1998) (Personal hygiene & training for technical staffs)
IIb (31 Dec 1999) (Handling of materials, Documentation and GMP for API)
IIc (31 Dec 2000) (Principles and practices relating to QC)
Phase III (31 Dec 2002) (HK GMP implemented)

The second topic was “Registration of Pharmaceutical Products & Substances”.(USA – CFR Title 21 Sec. 314.3; UK – Directive 2001/83/EC)

Pharmaceutical product included Poisons, Antibiotics, Dangerous Drugs, Product not belong to the above such as vitamins and minerals. The definition of a Pharmaceutical Product was stated in “Guidance Notes on Classification of Products as Pharmaceutical Products” at www.psdh.gov.hk .

The registration of pharmaceutical product based on Reg. 36(1) of Pharmacy & Poisons Ordinance to ensure the Quality, Safety and Efficacy.

During the application for registration, filled Form 6 and submitted the following supporting documents are requested.
i) complete master formula
ii) manufacturer’s license
iii) GMP certificate
iv) Free sale certificate
v) Certificate of analysis (CoA)
vi) Method of analysis
vii) Specifications
viii) Stability test data
ix) Clinical and scientific papers

The registration certificate is valid for a period of 5 years.

For more information:
Section1:
- Sec. (2) of the Pharmacy and Poisons Ordinance, Cap. 138.
- Reg. (29) – (35), Part VII of the Pharmacy and Poisons Regulations, Cap. 138A.
- Sec. (4-6) of the Dangerous Drugs Ordinance, Cap. 134.
Section2:
- Pharmacy & Poisons Ordinance – Section 29(q)
- Pharmacy & Poisons Regulations – Part VIII