The consultant
Mastura Nordin
B.Biomed.Sc. (Hons), Universiti Kebangsaan Malaysia.
Mastura began her career in sterile pharmaceutical manufacturing, progressing from Production Executive to Operations Manager before founding HBB Services Solution in 2011. She has extensive experience in cGMP, qualification and validation, with hands-on experience across pharmaceutical manufacturing facilities in Malaysia.
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
- Industry since1998
- SectorsPharmaceuticals, OTC, health supplements, traditional & homeopathy, veterinary, cosmetics
Experience
Career history
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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
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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
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Sep 2004 – Jan 2005
Consultant / Trainer
Applied Chemie (M) Sdn Bhd- cGMP training delivery
- Qualification and validation activities
- Third-party audits of client premises
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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
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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
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1999
Laboratory
Path-Lab, Mahkota Medical Centre, Melaka- Testing of medical specimens for diagnostic purposes
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1998 – 1999
Research & Development
Universiti Kebangsaan Malaysia- Assistance in R&D work
Training & workshops
Industry workshops & training
Sharing practical GMP and regulatory knowledge with industry since 2006.
Over the years, Mastura has conducted and contributed to numerous industry workshops, in-house training programmes and professional sessions covering GMP, quality systems, validation, materials handling and product registration.
Some examples of selected topics and engagements include:
- GMP Documentation & Basic ValidationUniversiti Kuala Lumpur, Malaysian Institute of Chemical & Bioengineering Technology, Alor Gajah, Melaka
- GMP Documentation & Basic ValidationMalaysian Biotechnology Corporation Sdn Bhd
- Materials HandlingFaculty of Pharmacy, UiTM
- Basic Concepts of Quality, GMP & Product RegistrationMajlis Amanah Rakyat (MARA)
Her training experience reflects a practical, industry-focused approach to GMP implementation, quality systems and regulatory compliance.
Professional development
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
Talk to a consultant, not a call centre.
Enquiries go directly to Mastura Nordin.
Start an enquiry WhatsApp +60 19-659 1775