Berita Ubat-ubatan
August 2000

Regulatory Control Beyond 2000

Separate Manufacturing Facilities For Cephalosporins

Warning Label for products - NSAID

Registration of Products Containing Insect Repellants

Warning for Products containing Hydroquinone

Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)
Licensing Update - June 2000

The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000

Additional Indications Approved for Registered Products

GMP News

Quality Control Training Course

Sources of products registered with DCA As At 30.6.2000

New Products Approved for Marketing in Malaysia

NPCB officers to contact

Clinical Trials

• PIC/S received Malaysia’s application on 4 February 2000

• PIC/S Committee held a meeting in Geneva on 17 – 18 February 2000

• Application has been evaluated and first report submitted by TGA, Australia in May 2000. Additional information was requested.

• Submitted additional information required in July 2000
• Received second evaluation report in August 2000. PIC/S requested supplementary information to be submitted by 29 September 2000.

• Malaysia has been invited to participate in the PIC/S Blood Expert Circle 2000, to be held in Saariselka, Finland on 30 August – 2 September 2000

• PIC/S has also invited Malaysia to attend the PIC/S Committee Meeting in Colmar, France in October 2000 and also to participate in the PIC/S Seminar on the inspection of products derived from biotechnologies

2. Pharmaceutical GMP Technical Working Group ( TWG )

• The TWG consisting of NPCB and MOPI members was set up in 1999.
• The 1^st Meeting was held on 11^th August 1999. Several meetings have been subsequently held later.
• MOPI proposed a comprehensive and systematic GMP training for the pharmaceutical industry. Training will be conducted on a continuous basis so as to provide a pool of trained personnel in the industry.
• Emphasis is to improve GMP standard of the local pharmaceutical industry.
• MOPI also proposed having an accreditation system for manufacturing premises.
• Proposals for training include GMP Modular Workshops, HPLC analytical method validation, Pharmaceutical facility design and Dissolution and Bioequivalence testing.
• Other areas discussed include GLP, validation guidelines and adoption of EU GMP guidelines for medicinal products.

3. Adoption of Eudralex GMP Guidelines 1997

• In tandem with Malaysia’s desire to join PIC/S and to gain global recognition, there is a need for the local industry to comply with current international standard of GMP.

• Discussions were held between NPCB and the local pharmaceutical industry last year to decide on the adoption of relevant GMP guidelines.

• Previously, Malaysia adopted the WHO Good Manufacturing Practices for Pharmaceutical Products, Technical Report Series, No : 823, 1992

• NPCB issued a circular to the local pharmaceutical industry regarding adoption of Eudralex – EU GMP Guidelines 1997, in November 1999.

• GMP inspections conducted currently are based on the Eudralex – EU GMP Guidelines 1997.
• The Eudralex EU GMP Guidelines 1997 may be purchased through the following local agent:-

  EBIC Malaysia
  Level 7, Wisma Hong Leong,
  18 Jalan Perak, 50450 Kuala Lumpur
  Tel: 603-2626298
  Fax: 603-2626198
  E-mail: ebic-kl@mol.net.my

The document may also be downloaded from the website (http://dg3.eudra.org/eudralex/vol-4/home.htm)

• International GMP and Quality Management Training Program
  Date : July 2000 – May 2001
  Venue : NPCB
  Topics include :

• Quality assurance and auditing
• Documentation and records
• GMP for utilities and services
• Facility and materials control
• GMP for equipment, cleaning and computer systems
• Process control – manufacturing and packaging
• Process validation, plans and protocols
• Good Laboratory Practice ( GLP )
• Staff development and training

The course is jointly organized by NPCB and MOPI with technical assistance by Intertech Global Access ( IGA ), Australia. About 40 local participants including 1 from Singapore have registered for the whole course. Two sessions of the first module were held on 10 – 11 July 2000 and 12 – 13 July 2000. Details of the course may br obtained from NPCB website.

• Pharmaceutical Facility Design
  Date : 5 – 6 June 2000
  Venue : Eastin Hotel, Petaling Jaya
  Topics included :

• Building layout, material and personnel
• HVAC design
• Water systems design
• Auditing designs and existing facilities

Almost 50 participants from the local pharmaceutical industry as well as from Singapore attended the two-day seminar organized by MOPI with technical assistance by Raytheon Engineers and Constructors, Singapore.

• Validation of Analytical Methods Workshop
  Date : 28 – 29 August 2000
  Venue : Universiti Sains Malaysia, Pulau Pinang
  Topics include :

• Linearity and range
• System suitability
• Limit of detection and quantification of analytical method
• Precision and accuracy
• Ruggedness of assay method
• Degradation mechanism of pharmaceuticals and stability indicating methods

5. Revised Site Master File

• Site Master File, BPFK/P/GP/06, ISBN 983 – 9870 – 13 – 0, published in October 1984 has been reviewed, keeping abreast with current international requirements.
• The proposed new edition of Site Master File will be published in 2 versions, namely English and Bahasa Malaysia. The Bahasa Malaysia version is to enable better understanding of the requirements for the traditional medicines manufacturing premises.
• The new guidelines will be made available on the BPFK website ( http://www.bpfk.gov.my/ )