Halal Pharmaceutical Production Premises and Equipment

NPCB MS 2424 2012 covers pharmaceutical products in finished dosage forms for human use, including both prescription and non-prescription medicinal products, which are registered with the Drug Control Authority, Ministry of Health Malaysia. This includes biopharmaceuticals, radiopharmaceuticals, traditional medicines, and investigational medicinal products, and it is part of the ______ reference.

NPCB MS 2424 2012 requires that the pharmaceuticals are designed and developed in a way that comply with the requirements of ______ and GMP.

Under NPCB MS 2424 2012, the processing line must be operated for halal pharmaceuticals only, and if the processing line is contaminated with najs, then ______ cleansing shall be required.

The requirements described in the PIC/S GMP Guidelines and PIC/S Annexes are an integral part of the standard for ______ pharmaceuticals in GMP.

The need to avoid – any risks of contamination from environment – cross-contamination, mix up – risk of contamination of nonhalal [4.9] 36 NPCB 3.PREMISES & EQUIPMENT Converting into halal production line [Annex A] – supervised & verified by Competent authority Shall be operated for halal ______ products only Repetition in converting the line to najs line and back to halal line shall not be permitted [4.9] Dedicated & self contained for halal products [4.10] 37 NPCB Premises and equipment [4.9] effectively separated and well insulated from pig farm activities and others, in order to prevent cross contamination through air, water, sewerage, personnel and equipment shall observe to an Islamic value and practice NPCB AREA CLASSIFICATIONS BLACK [LUAR] GREY [1ST CHG] WHITE [PRODN] WHITE [2ND CHG] CLEAN AREA 39 NPCB Hormone Production 40 NPCB 4.DOCUMENTATION Complete history of each batch from starting material to finished products, traceability [Halal cert] Batch Processing Records or BMR, SOPs, Formulas etc Evidence of materials origin, approved by authorised Muslim personnel [4.13] 41 NPCB 5.

Converting into halal production line [Annex A] – supervised & verified by Competent authority Shall be operated for halal ______ products only Repetition in converting the line to najs line and back to halal line shall not be permitted [4.9] Dedicated & self contained for halal products [4.10] 37 NPCB Premises and equipment [4.9] effectively separated and well insulated from pig farm activities and others, in order to prevent cross contamination through air, water, sewerage, personnel and equipment shall observe to an Islamic value and practice NPCB AREA CLASSIFICATIONS BLACK [LUAR] GREY [1ST CHG] WHITE [PRODN] WHITE [2ND CHG] CLEAN AREA 39 NPCB Hormone Production 40 NPCB 4.DOCUMENTATION Complete history of each batch from starting material to finished products, traceability [Halal cert] Batch Processing Records or BMR, SOPs, Formulas etc Evidence of materials origin, approved by authorised Muslim personnel [4.13] 41 NPCB 5.

Premises and equipment [4.9] effectively separated and well insulated from pig farm ______ and others, in order to prevent cross contamination through air, water, sewerage, personnel and equipment shall observe to an Islamic value and practice NPCB AREA CLASSIFICATIONS BLACK [LUAR] GREY [1ST CHG] WHITE [PRODN] WHITE [2ND CHG] CLEAN AREA 39 NPCB Hormone Production 40 NPCB 4.DOCUMENTATION Complete history of each batch from starting material to finished products, traceability [Halal cert] Batch Processing Records or BMR, SOPs, Formulas etc Evidence of materials origin, approved by authorised Muslim personnel [4.13] 41 NPCB 5.

Complete history of each batch from starting material to finished products, traceability [Halal cert] Batch Processing Records or BMR, SOPs, Formulas etc Evidence of materials origin, approved by authorised Muslim personnel [4.13] 41 NPCB 5.

[email protected] NPCB HALAL Pharmaceuticals: General Guidelines MS 2424 2012 HALAL Cosmetics: General Guidelines MS 2200: Part 1: 2008 80 NPCB www.bpfk.gov.my 81 81 NPCB Some Tips 82 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Gelatin Capsules, emulsifier, filler 1.Skin, bones, joints (bovine, porcine).Collagen derivatives. 2.Vegetables 83 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Glycerine Glycerol 1.Lard 2.Vegetables 3.Byproducts of biodiesel productions Diluent, antibacterial, sweetener, preservatives (found in syrup, toothpaste, soaps, shampoo etc) 84 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Alcohol (ethanol drinks) 1.Fermentations 2.Chemicals Solvent, Antiseptic (methanolreagent) 85 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Stearates, Lubricants e.g Binder Magnesium, Stearic acid, calcium 1.Animal Fats, Lard or fatty acids from pig’s stomach) 2.Vegetable (palm oil.Coconut, soybean, castpr oil, sunflower) 86 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Enzymes e.g.Trypsin Media for microbial growth (TSB) 1.Pig’s Pancreas ACTH Hormones, corticotrophin 2.Pig’s Pituitary Gland 87 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Heparin 1.Pig’s intestine 2.Bovine Anti-Clotting Agent Also used in ‘coating’ in medical devices e.g.catheter, heart transplant devices 88

Gelatin Capsules, emulsifier, filler 1.Skin, bones, joints (bovine, porcine).Collagen derivatives. 2.Vegetables 83 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Glycerine Glycerol 1.Lard 2.Vegetables 3.Byproducts of biodiesel productions Diluent, antibacterial, sweetener, preservatives (found in syrup, toothpaste, soaps, shampoo etc) 84 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Alcohol (ethanol drinks) 1.Fermentations 2.Chemicals Solvent, Antiseptic (methanolreagent) 85 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Stearates, Lubricants e.g Binder Magnesium, Stearic acid, calcium 1.Animal Fats, Lard or fatty acids from pig’s stomach) 2.Vegetable (palm oil.Coconut, soybean, castpr oil, sunflower) 86 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Enzymes e.g.Trypsin Media for microbial growth (TSB) 1.Pig’s Pancreas ACTH Hormones, corticotrophin 2.Pig’s Pituitary Gland 87 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Heparin 1.Pig’s intestine 2.Bovine Anti-Clotting Agent Also used in ‘coating’ in medical devices e.g.catheter, heart transplant devices 88

Glycerine Glycerol 1.Lard 2.Vegetables 3.Byproducts of biodiesel productions Diluent, antibacterial, sweetener, preservatives (found in syrup, toothpaste, soaps, shampoo etc) 84 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Alcohol (ethanol drinks) 1.Fermentations 2.Chemicals Solvent, Antiseptic (methanolreagent) 85 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Stearates, Lubricants e.g Binder Magnesium, Stearic acid, calcium 1.Animal Fats, Lard or fatty acids from pig’s stomach) 2.Vegetable (palm oil.Coconut, soybean, castpr oil, sunflower) 86 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Enzymes e.g.Trypsin Media for microbial growth (TSB) 1.Pig’s Pancreas ACTH Hormones, corticotrophin 2.Pig’s Pituitary Gland 87 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Heparin 1.Pig’s intestine 2.Bovine Anti-Clotting Agent Also used in ‘coating’ in medical devices e.g.catheter, heart transplant devices 88

Stearates, Lubricants e.g Binder Magnesium, Stearic acid, calcium 1.Animal Fats, Lard or fatty acids from pig’s stomach) 2.Vegetable (palm oil.Coconut, soybean, castpr oil, sunflower) 86 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Enzymes e.g.Trypsin Media for microbial growth (TSB) 1.Pig’s Pancreas ACTH Hormones, corticotrophin 2.Pig’s Pituitary Gland 87 NPCB Commonly used SUBSTANCE FUNCTION SOURCES &COMMENTS Heparin 1.Pig’s intestine 2.Bovine Anti-Clotting Agent Also used in ‘coating’ in medical devices e.g.catheter, heart transplant devices 88

Documentation Ch. 5.Production Ch. 6.Quality Control Ch. 7.Contract Manufacture and Analysis Ch. 8.Complaint and Product Recall Ch. 9.Self Inspection Annexes 1-20 (specific) 29 29 NPCB Halal ‘built-in’ Source of materials Things that come in Contact with Recog.body Compliance to PIC/S Guide to Good Manufacturing Practice For medicinal Products & Annexes Halal Assurance System Halal Committee Halal Facility etc NPCB 1.QUALITY MANAGEMENT SYSTEM Quality Assurance Good Manufacturing Practice Product Quality Review [5 long Clauses] Ensure halal pharma manufactured according to halal requirements [4.1] 31 NPCB QUALITY MANAGEMENT SYSTEM Developed, established, implemented Policies and objectives Organisational structure, functions Responsibilities, procedures QC and specifications 32 NPCB 2.PERSONNEL sufficient & qualified, separate people responsible for production and quality control (independent of each other) appropriately trained in GMP, regulatory requirements & understands their responsibilities 33 NPCB 2.PERSONNEL shall establish a ______ committee which is led by a trained Muslim shall consist of purchasing personnel and fulfill a minimum 2/3 Muslim quorum & they are responsible to ensure the effectiveness in the implementation of the Halal Assurance System [4.6] 34 NPCB 2.PERSONNEL Continuous training on Halal, approved by H Committee, periodically assessed[4.7] Strict personal hygiene is an integral requirement for halal [4.8] 35 NPCB 3.

Documentation Ch. 5.Production Ch. 6.Quality Control Ch. 7.Contract Manufacture and Analysis Ch. 8.Complaint and Product Recall Ch. 9.Self Inspection Annexes 1-20 (specific) 29 29 NPCB Halal ‘built-in’ Source of materials Things that come in Contact with Recog.body Compliance to PIC/S Guide to Good Manufacturing Practice For medicinal Products & Annexes Halal Assurance System Halal Committee Halal Facility etc NPCB 1.QUALITY MANAGEMENT SYSTEM Quality Assurance Good Manufacturing Practice Product Quality Review [5 long Clauses] Ensure halal pharma manufactured according to halal requirements [4.1] 31 NPCB QUALITY MANAGEMENT SYSTEM Developed, established, implemented Policies and objectives Organisational structure, functions Responsibilities, procedures QC and specifications 32 NPCB 2.PERSONNEL sufficient & qualified, separate people responsible for production and quality control (independent of each other) appropriately trained in GMP, regulatory requirements & understands their responsibilities 33 NPCB 2.PERSONNEL shall establish a Halal committee which is led by a trained Muslim shall consist of purchasing personnel and fulfill a minimum 2/3 Muslim quorum & they are responsible to ensure the effectiveness in the implementation of the ______ Assurance System [4.6] 34 NPCB 2.PERSONNEL Continuous training on Halal, approved by H Committee, periodically assessed[4.7] Strict personal hygiene is an integral requirement for halal [4.8] 35 NPCB 3.

Documentation Ch. 5.Production Ch. 6.Quality Control Ch. 7.Contract Manufacture and Analysis Ch. 8.Complaint and Product Recall Ch. 9.Self Inspection Annexes 1-20 (specific) 29 29 NPCB Halal ‘built-in’ Source of materials Things that come in Contact with Recog.body Compliance to PIC/S Guide to Good Manufacturing Practice For medicinal Products & Annexes Halal Assurance System Halal Committee Halal Facility etc NPCB 1.QUALITY MANAGEMENT SYSTEM Quality Assurance Good Manufacturing Practice Product Quality Review [5 long Clauses] Ensure halal pharma manufactured according to halal requirements [4.1] 31 NPCB QUALITY MANAGEMENT SYSTEM Developed, established, implemented Policies and objectives Organisational structure, functions Responsibilities, procedures QC and specifications 32 NPCB 2.PERSONNEL sufficient & qualified, separate people responsible for production and quality control (independent of each other) appropriately trained in GMP, regulatory requirements & understands their responsibilities 33 NPCB 2.PERSONNEL shall establish a Halal committee which is led by a trained Muslim shall consist of purchasing personnel and fulfill a minimum 2/3 Muslim quorum & they are responsible to ensure the effectiveness in the implementation of the Halal Assurance System [4.6] 34 NPCB 2.PERSONNEL Continuous training on ______, approved by H Committee, periodically assessed[4.7] Strict personal hygiene is an integral requirement for halal [4.8] 35 NPCB 3.

Documentation Ch. 5.Production Ch. 6.Quality Control Ch. 7.Contract Manufacture and Analysis Ch. 8.Complaint and Product Recall Ch. 9.Self Inspection Annexes 1-20 (specific) 29 29 NPCB Halal ‘built-in’ Source of materials Things that come in Contact with Recog.body Compliance to PIC/S Guide to Good Manufacturing Practice For medicinal Products & Annexes Halal Assurance System Halal Committee Halal Facility etc NPCB 1.QUALITY MANAGEMENT SYSTEM Quality Assurance Good Manufacturing Practice Product Quality Review [5 long Clauses] Ensure ______ pharma manufactured according to halal requirements [4.1] 31 NPCB QUALITY MANAGEMENT SYSTEM Developed, established, implemented Policies and objectives Organisational structure, functions Responsibilities, procedures QC and specifications 32 NPCB 2.PERSONNEL sufficient & qualified, separate people responsible for production and quality control (independent of each other) appropriately trained in GMP, regulatory requirements & understands their responsibilities 33 NPCB 2.PERSONNEL shall establish a Halal committee which is led by a trained Muslim shall consist of purchasing personnel and fulfill a minimum 2/3 Muslim quorum & they are responsible to ensure the effectiveness in the implementation of the Halal Assurance System [4.6] 34 NPCB 2.PERSONNEL Continuous training on Halal, approved by H Committee, periodically assessed[4.7] Strict personal hygiene is an integral requirement for halal [4.8] 35 NPCB 3.