Profile
Regulatory work built on a manufacturing floor, not a desk.
Before consulting, Mastura Nordin worked inside sterile pharmaceutical production — qualifying sterile facilities, validating aseptic processes and training production staff. That background is what makes the advice practical: the recommendations come from someone who has had to run the system being recommended.
HBB was founded to serve small and medium Malaysian manufacturers, product holders, distributors and wholesalers — companies that need the same regulatory standard as multinationals, but advice and rates sized to how they actually operate.
- QualificationDegree in Bio-Medical Science, Faculty of Allied Health Sciences, Universiti Kebangsaan Malaysia (B.Biomed.Sc. [Hons.])
- SpecialisationGMP, product registration, licensing, regulatory affairs and training
- MembershipMember of ISPE (International Society of Pharmaceutical Engineering) since 2006
- Industry since1998
- SectorsPharmaceuticals, OTC, health supplements, traditional & homeopathy, veterinary, cosmetics
Experience
Career history
-
2011 – present
Founder & Principal Consultant
HBB Services Solution- Consultancy in product registration, cosmetic notification and PIF, licensing and regulatory affairs
- GMP and GDP consultation for manufacturing plants, on retainer
- In-house GMP and cleanroom aseptic technique training
- GMP / quality audits and vendor evaluation
-
Feb 2006 – Jul 2011
Operation Manager
A1 Consultancy & Integrated Services Sdn Bhd- Managed the operation department; consultant and trainer
- Assisted in preparation and planning of new pharmaceutical factory design
- Built documentation systems for clients
- cGMP training, qualification and validation activities
- Product registration and updating; regulatory issues
- Third-party audits of client premises
-
Sep 2004 – Jan 2005
Consultant / Trainer
Applied Chemie (M) Sdn Bhd- cGMP training delivery
- Qualification and validation activities
- Third-party audits of client premises
-
1999 – Aug 2004
Production Executive — Sterile & Cephalosporin
Kotra Pharma (M) Sdn Bhd- Involved in planning and design of the sterile production facility
- Assisted the Plant Manager in setting up sterile department operations
- Qualification of sterile facility: HVAC system, steam, compressed air system, water-for-injection system, clean rooms, sterilizers, depyrogenation oven and related equipment
- Participated in all sterile process validations, including media simulation runs for aseptic processes
- Scheduled and managed operation for production of sterile powders and gels
- Conducted staff training in the sterile department and other departments
- Responsible for assuring the effectiveness of Quality Assurance in the Sterile Department
-
1999 – 2000
In-Vitro Fertilization (IVF) Laboratory
Kotra Pharma- Production of sterile media, 2 ml in 10 ml vials, batch size 300 vials
- Microbial testing — total plate count
- R&D related tests on semen samples: sperm count, pH, osmolality
-
1999
Laboratory
Path-Lab, Mahkota Medical Centre, Melaka- Testing of medical specimens for diagnostic purposes
-
1998 – 1999
Research & Development
Universiti Kebangsaan Malaysia- Assistance in R&D work
Papers & speaking
Presented at industry workshops
-
15 – 16 July 2009
“GMP Documentation & Basic Validation”
GMP in-house training, Universiti Kuala Lumpur, Malaysian Institute of Chemical & Bioengineering Technology, Alor Gajah, Melaka -
5 – 6 Oct 2009
“GMP Documentation & Basic Validation”
GMP workshop, Malaysian Biotechnology Corporation Sdn Bhd -
22 – 23 May 2006
“Materials Handling”
GMP workshop, Faculty of Pharmacy, UiTM -
17 – 18 Apr 2006
“Basic & Concept of Quality/GMP and Product Registration”
Presented paper and assisted, organised by Majlis Amanah Rakyat (MARA)
Professional development, 1999 – 2010
International and national GMP programmes
- International GMP training programme, jointly organised by MOPI, NPCB and Interpharm Australia — Module 2 GMP Documentation & Records; Module 4 cGMP Engineering & Validation; Module 7 Facility, Materials & Environment Control; Module 8 Process Control (Manufacturing & Packaging)
- Validation Practices (Module 5), NPCB training course, organised by MOPI
- National GMP Seminar and National GMP Conference, organised by NPCB, Ministry of Health
- Control of Quality & Safety of Traditional Medicine & Health Supplements — MOPI, NPCB
- Current regulatory requirements for health supplements — NPCB
- GMP Seminar on Veterinary Products; Veterinary Products Registration Seminar — NPCB
- Workshop on online submission of veterinary product registration
- Biotech & Biosimilar Products Workshop
Technical and equipment training
- Limulus Amebocyte Lysate Seminar — Choice-care Sdn Bhd
- GMP for Pharmaceutical Packaging Material Suppliers — MOPI & NPCB, MOH
- S/S tubes & fittings for the pharmaceutical industry — CryoGas Tech Sdn Bhd
- Biological Indicators for Industries — Choice-care Sdn Bhd
- Integrity testing for filters — PALL Corporation
- Basic of filtration & filter integrity testing — Sartorius (M) Sdn Bhd
- HEPA filter integrity test — Nextech Sdn Bhd
- Forum: Bio Tech Scaling — Millipore
- Total marking and coding solutions — Coding Tech (M) Sdn Bhd
Business, audit and professional skills
- ISO 9001:2000 Internal Audit Training — CAI Oxbridge
- Seminar Pakarunding — MARA
- Effective Communication & the Educator — PSMB
- Industrial Business Solution Seminar — TM Bhd
- Service Tax — KDRM; LHDN briefings on company tax and rebates
- Microsoft Word Level 1 — Cempaka Technology Sdn Bhd
Client references
30 organisations across Selangor, Kuala Lumpur, Johor, Melaka, Penang, Kedah and Pahang.
Talk to a consultant, not a call centre.
Enquiries go directly to Mastura Nordin.
Start an enquiry WhatsApp +60 19-659 1775