Starting a pharmaceutical manufacturing company in South Africa requires much more than registering a company and purchasing production machinery.

A pharmaceutical manufacturer must establish:

• A legally registered business
• Suitable and licensed pharmacy premises
• A responsible pharmacist
• A Good Manufacturing Practice-compliant facility
• Production and quality-control systems
• A pharmaceutical quality-management system
• A Site Master File
• Qualified technical personnel
• A SAHPRA manufacturing licence
• Product registrations or authorisations

A manufacturing licence authorises the approved facility and activities. It does not automatically permit the company to manufacture and sell every proposed medicine.

Quick Answer

To start a pharmaceutical manufacturing unit in South Africa, the usual practical sequence is:

1. Decide which medicines and dosage forms you will manufacture.
2. Register the company in South Africa.
3. Select an appropriate industrial site.
4. Appoint a responsible pharmacist.
5. Apply for the relevant pharmacy-premises licence.
6. Record the pharmacy, pharmacy owner and responsible pharmacist through the applicable SAPC process.
7. Design and construct the facility according to South African GMP requirements.
8. Install and qualify production, laboratory and utility equipment.
9. Prepare the Site Master File and quality-management system.
10. Submit SAHPRA Form GLF-LIC-01A with supporting documents and fees.
11. Complete the SAHPRA GMP inspection.
12. Correct any inspection deficiencies.
13. Obtain the manufacturing licence.
14. Obtain registration or authorisation for each medicine before commercial sale.

SAHPRA issues licences to manufacture, import or export medicines and scheduled substances under Section 22C of the Medicines and Related Substances Act. The current application form is GLF-LIC-01A.

Which Authority Regulates Pharmaceutical Manufacturing?

The main authorities involved are:

South African Health Products Regulatory Authority

SAHPRA regulates:

• Pharmaceutical establishment licensing
• GMP inspections
• Medicine registration
• Scheduled substances
• Imports and exports
• Product quality
• Pharmacovigilance
• Recalls and regulatory compliance

SAHPRA’s Pharma Licensing unit issues licences to manufacturers, importers, exporters, wholesalers and distributors of medicines or scheduled substances.

National Department of Health

The National Department of Health administers pharmacy-premises licensing under the Pharmacy Act in collaboration with SAPC and SAHPRA.

South African Pharmacy Council

SAPC is involved in matters such as:

• Recording of the pharmacy
• Recording of the pharmacy owner
• Registration of the responsible pharmacist
• Pharmacy standards
• Professional pharmacy practice

The NDoH’s current guidance states that new pharmacy-premises licence applications are submitted online through the portal hosted by SAPC.

Legal Framework

Pharmaceutical manufacturing in South Africa is regulated principally under:

• Medicines and Related Substances Act, 1965
• Regulations issued under the Medicines Act
• Pharmacy Act, 1974
• Applicable pharmacy regulations
• South African Guide to Good Manufacturing Practice for Medicines
• Product-registration guidelines
• Environmental, occupational-safety and municipal laws

The Medicines Act, as amended, established the framework for SAHPRA and licensing of manufacturers and importers of medicines and active pharmaceutical ingredients.

Is a Pharmaceutical Manufacturing Licence Compulsory?

Yes.

A business cannot legally manufacture medicines or scheduled substances merely because it has:

• Company registration
• Industrial premises
• Pharmaceutical machinery
• Qualified employees
• A contract from another company
• A product formula
• A registered trademark

The facility must hold the applicable SAHPRA licence before conducting licensed commercial manufacturing activities.

The licence specifies matters such as:

• Licensed company
• Physical manufacturing address
• Approved operations
• Dosage forms
• Manufacturing activities
• Import or export activities, where applicable
• Contract testing, where applicable
• Licence conditions

Current Manufacturing-Licence Application Form

The current SAHPRA form is:

GLF-LIC-01A – Licence Application to Manufacture, Import or Export Medicines or Scheduled Substances, including Contract Testing Laboratories

The form is used for:

• New manufacturing licences
• Licence renewals
• Licence amendments
• Import activities
• Export activities
• Contract testing laboratories

It is issued under Sections 22C and 22D of the Medicines Act, read with Regulations 23 and 24.

Current SAHPRA Guidelines

Applicants should use the latest versions of:

Document	Purpose
SAHPGL-LIC-01	Licence to manufacture, import or export
GLF-LIC-01A	Manufacturing/import/export licence application
SAHPGL-INSP-02	South African GMP guide for medicines
SAHPGL-INSP-04	Preparation of the Site Master File
SAHPRA fee guideline	Application and inspection fees

As of August 2026, SAHPGL-LIC-01 Version 4 was updated on April 13, 2026, and the South African GMP guide, SAHPGL-INSP-02 Version 10, was updated on April 24, 2026.

Step 1: Decide What You Will Manufacture

Before selecting land or preparing a factory layout, decide:

• Product category
• Dosage form
• Production capacity
• Product market
• Whether products are sterile or non-sterile
• Whether the facility will manufacture active ingredients
• Whether testing will be in-house or contracted
• Whether the company will import or export
• Whether products are human, veterinary or complementary medicines

Possible product categories include:

• Conventional human medicines
• Biological medicines
• Veterinary medicines
• Complementary medicines
• Active pharmaceutical ingredients
• Medical devices
• Cannabis products for medicinal purposes

These categories do not necessarily follow the same application route.

Step 2: Prepare a Feasibility Report

A pharmaceutical feasibility report should examine:

• Market demand
• Dosage forms
• Manufacturing capacity
• Machinery
• Land and construction
• HVAC
• Pharmaceutical water systems
• Quality-control laboratory
• Technical staff
• Utilities
• Product-development cost
• Product-registration cost
• Validation
• Stability studies
• Working capital
• Distribution
• Export potential

Do not base the investment decision only on the cost of production machinery. Facility construction, utilities, quality systems, testing and regulatory work can represent a major part of the project.

Step 3: Register the Business

The manufacturing company should be properly registered in South Africa.

Business documents commonly include:

• CIPC registration documents
• Company registration certificate
• Memorandum of Incorporation
• Details of directors
• Shareholding or ownership information
• Registered address
• Tax registration
• Banking details
• Board resolution authorising the project
• Authorised representative details

SAHPRA currently asks applicants to submit CIPC, CIPRO or DTI documents proving ownership of the business as part of the licensing package.

Step 4: Select a Suitable Industrial Site

The site should be appropriate for pharmaceutical manufacturing.

Check:

• Municipal zoning
• Industrial-use permission
• Environmental restrictions
• Availability of electricity
• Backup-power feasibility
• Water supply
• Drainage
• Waste disposal
• Road access
• Staff access
• Security
• Fire safety
• Expansion potential
• Nearby contamination sources

Avoid selecting a site close to operations that could create:

• Dust
• Fumes
• Chemical contamination
• Microbial contamination
• Pest problems
• Excessive vibration
• Flooding risk

Obtain professional advice before purchasing land or signing a long-term lease.

Step 5: Appoint a Responsible Pharmacist

The responsible pharmacist is a central person in the pharmaceutical establishment.

The responsible pharmacist should be appropriately registered and acceptable under the South African pharmacy framework.

His or her responsibilities may include:

• Regulatory compliance
• Pharmaceutical quality system oversight
• GMP implementation
• Batch-release oversight
• Product storage
• Complaint handling
• Recall coordination
• Staff supervision
• Licence maintenance
• Interaction with authorities
• Ensuring compliance with licence conditions

SAHPRA’s licence checklist requires either proof of registration as the responsible pharmacist or the relevant SAPC case number.

The responsible pharmacist should not be appointed merely for paperwork. He or she must have genuine authority, sufficient time and access to the facility.

Step 6: Apply for Pharmacy-Premises Licensing

A pharmaceutical manufacturing establishment may also need the applicable pharmacy-premises licence through the National Department of Health process.

The NDoH administers pharmacy-premises licences in collaboration with SAPC and SAHPRA. Applications for new pharmacy premises are currently made online through the portal hosted by SAPC.

SAHPRA’s manufacturer-licence checklist asks for:

• NDoH premises licence, or proof that the application has been submitted
• SAPC certificate recording the pharmacy, or SAPC case number
• SAPC certificate recording the pharmacy owner, or SAPC case number
• Responsible pharmacist registration, or SAPC case number

These processes should be started early because they are linked to the final SAHPRA application.

Step 7: Prepare the Pharmaceutical Factory Layout

The layout should be prepared by professionals who understand pharmaceutical GMP.

It should show:

• Site boundaries
• Production areas
• Warehouses
• Quality-control laboratories
• Quality-assurance offices
• Personnel entrances
• Material entrances
• Change rooms
• Airlocks
• Washrooms
• Utility areas
• Waste routes
• Equipment placement
• Personnel flow
• Material flow
• HVAC zoning
• Pressure differentials
• Emergency exits
• Fire-safety equipment

The layout should reduce:

• Cross-contamination
• Mix-ups
• Uncontrolled movement
• Entry of unauthorized personnel
• Confusion between approved and rejected materials
• Contact between clean and dirty operations

Personnel and Material Flow

Personnel and materials should not move randomly through the facility.

A typical material flow may be:

1. Receipt
2. Quarantine
3. Sampling
4. Quality-control testing
5. Approval
6. Dispensing
7. Manufacturing
8. Packing
9. Finished-goods quarantine
10. Batch release
11. Dispatch

Separate routes may be required for:

• Personnel
• Raw materials
• Packing materials
• Finished goods
• Waste
• Returned products
• Recalled products

Step 8: Construct the Facility According to GMP

The factory should be constructed with materials that permit:

• Easy cleaning
• Effective sanitation
• Maintenance
• Prevention of dust accumulation
• Pest control
• Prevention of water leakage
• Control of contamination

Suitable finishes may be needed for:

• Floors
• Walls
• Ceilings
• Corners
• Doors
• Windows
• Service penetrations

The applicable construction standard depends on whether the section is:

• Non-sterile
• Sterile
• Potent-product
• Hormonal
• Cytotoxic
• Biological
• Microbiological
• High-containment

Step 9: Establish Pharmaceutical Utilities

Important utilities may include:

• HVAC system
• Purified-water system
• Water for injection, where applicable
• Clean steam
• Compressed air
• Vacuum system
• Boiler
• Chilled-water system
• Electrical backup
• Building-management system
• Environmental-monitoring system

Utilities should be:

• Properly designed
• Installed
• Qualified
• Monitored
• Maintained
• Documented

HVAC Requirements

HVAC systems may need to control:

• Temperature
• Relative humidity
• Air filtration
• Air changes
• Pressure differentials
• Dust
• Cross-contamination
• Product protection
• Personnel protection

The design must match the product and process risk.

A simple oral-liquid factory and a sterile-injection factory will not require the same HVAC design.

Pharmaceutical Water System

The required water quality depends on the intended product.

Possible systems include:

• Potable water
• Purified water
• Water for injection
• Clean steam

The water system should have documented:

• Design qualification
• Installation qualification
• Operational qualification
• Performance qualification
• Sampling points
• Microbiological monitoring
• Chemical monitoring
• Sanitisation
• Maintenance

Step 10: Install Manufacturing Machinery

Machinery depends on dosage forms and production capacity.

Tablet Manufacturing Section

Typical equipment may include:

• Dispensing booth
• Sifter
• Mill
• Rapid mixer granulator
• Fluid-bed dryer
• Tray dryer
• Blender
• Tablet compression machine
• Deduster
• Metal detector
• Tablet coater
• Tablet inspection machine
• Blister or bottle packing line

Capsule Manufacturing Section

Equipment may include:

• Sifter
• Blender
• Granulation equipment
• Capsule-filling machine
• Capsule-polishing machine
• Metal detector
• Capsule inspection
• Blister or bottle packing line

Oral-Liquid Section

Equipment may include:

• Purified-water storage tank
• Sugar-syrup vessel
• Manufacturing vessel
• Storage vessel
• Homogenizer
• Colloid mill
• Filter
• Transfer pump
• Bottle-washing machine
• Filling machine
• Capping machine
• Labelling machine

Dry-Powder Section

Equipment may include:

• Sifter
• Blender
• Powder-filling machine
• Sachet-packing machine
• Bottle-filling machine
• Capping and labelling systems
• Dust-extraction system

Cream and Ointment Section

Equipment may include:

• Oil-phase vessel
• Water-phase vessel
• Manufacturing vessel
• Vacuum emulsifier
• Homogenizer
• Colloid mill
• Storage vessel
• Tube-filling machine
• Tube-sealing machine
• Jar-filling machine

Suppository Section

Typical equipment may include:

• Melting vessel
• Mixing vessel
• Temperature-control system
• Suppository-filling machine
• Cooling unit
• Packing machine

Inhaler and Spray Section

Depending on the product:

• Pressure vessels
• Filling equipment
• Crimping machine
• Leak-testing system
• Aerosol safety controls
• Explosion-protected equipment
• Environmental controls

Sterile Injectable Section

Sterile-product manufacturing may require:

• Component washing
• Autoclaves
• Depyrogenation tunnel
• Solution-preparation vessels
• Sterile filtration
• Aseptic filling
• Vial or ampoule sealing
• Lyophilizer
• Restricted-access barrier system
• Isolator, where appropriate
• Visual inspection
• Container-closure integrity testing
• Environmental monitoring

Sterile production carries significantly greater technical and regulatory risk than non-sterile manufacturing.

Separate Sections for Different Dosage Forms

Different products may require separate rooms, areas or buildings depending on contamination risk.

Special consideration is required for products such as:

• Penicillins
• Cephalosporins
• Hormones
• Cytotoxic medicines
• Highly potent products
• Biological products
• Live microorganisms
• Sensitising substances

Do not assume that all dosage forms can share the same production area merely by cleaning the equipment.

A documented contamination-control strategy and quality-risk assessment are needed.

Medical Devices Require a Separate Route

Syringes, diagnostic products, surgical products and other medical devices should not automatically be included under an ordinary pharmaceutical manufacturing licence.

SAHPRA has a separate medical-device manufacturer application, GLF-MD-06A, under the medical-device regulatory system.

Classify each proposed product before designing the facility.

Complementary and Ayurvedic Medicines

In South Africa, Ayurveda is recognised as one of the disciplines included in the complementary-medicines framework.

SAHPRA identifies disciplines including:

• Ayurveda
• Aromatherapy
• Homeopathy
• Traditional Chinese Medicine
• Unani Tibb
• Western Herbal Medicine

Complementary medicines must be manufactured, imported, exported, wholesaled or distributed by the holder of the relevant Section 22C licence. Product-registration and category-specific requirements must also be checked.

Do not treat an Ayurvedic, herbal or health-supplement product as an ordinary pharmaceutical medicine without confirming its South African classification.

Quality-Control Laboratory

The factory should have adequate quality-control capability for its products and processes.

Laboratory sections may include:

• Chemical laboratory
• Instrumental laboratory
• Microbiology laboratory
• Sterility-testing area
• Stability section
• Sampling room
• Reference-standard room
• Retained-sample room

Typical Quality-Control Equipment

Depending on products, equipment may include:

• Analytical balances
• pH meter
• UV-visible spectrophotometer
• High-performance liquid chromatograph
• Gas chromatograph
• Dissolution tester
• Disintegration tester
• Friability tester
• Hardness tester
• Moisture analyser
• Karl Fischer apparatus
• Viscometer
• Melting-point apparatus
• Incubators
• Autoclave
• Laminar-flow cabinet
• Stability chambers
• Microbiological-testing equipment

The equipment list should be based on actual specifications, pharmacopoeial tests and registered product requirements.

Can Quality-Control Testing Be Outsourced?

Some specialised testing may be assigned to an authorised contract testing laboratory.

However:

• Responsibilities must be defined in a written quality agreement.
• The laboratory should hold the applicable authorisation.
• Methods and specifications must be approved.
• Samples must remain traceable.
• Results must be reviewed by the manufacturer’s quality unit.
• Original data should remain accessible.
• Out-of-specification results must be properly investigated.

Outsourcing testing does not transfer the manufacturer’s ultimate responsibility for product quality.

Quality Assurance and Quality Control

Quality assurance and quality control are separate but connected functions.

Quality Assurance Responsibilities

• Pharmaceutical quality system
• Documentation
• Change control
• Deviations
• CAPA
• Risk management
• Validation
• Training
• Self-inspection
• Supplier qualification
• Product-quality review
• Complaints
• Recalls
• Data integrity

Quality Control Responsibilities

• Raw-material testing
• Packing-material testing
• In-process testing
• Finished-product testing
• Environmental monitoring
• Stability testing
• Reference standards
• Retained samples
• Analytical-method control
• Laboratory investigations

The quality unit should have enough authority to approve or reject materials and batches independently of production pressure.

Site Master File

A Site Master File provides an overview of the facility and its pharmaceutical quality systems.

SAHPRA maintains a specific guideline, SAHPGL-INSP-04, for preparing Site Master Files for pharmaceutical sites.

A Site Master File commonly covers:

• Company information
• Licensed activities
• Quality-management system
• Personnel
• Premises
• Equipment
• Documentation
• Production
• Quality control
• Contract activities
• Distribution
• Complaints and recalls
• Self-inspections

The document should describe the actual site. It should not be a copied generic document.

Standard Operating Procedures

The facility should have controlled SOPs for areas such as:

• Document control
• Staff training
• Entry and gowning
• Cleaning and sanitation
• Equipment operation
• Equipment cleaning
• Calibration
• Maintenance
• Material receipt
• Sampling
• Material release
• Dispensing
• Manufacturing
• Packing
• Batch release
• Deviation management
• CAPA
• Change control
• Complaints
• Recalls
• Returns
• Stability
• Waste disposal
• Data backup
• Computerised systems
• Self-inspection

Equipment Qualification and Validation

Major equipment and systems should be qualified.

Qualification may include:

• Design qualification
• Installation qualification
• Operational qualification
• Performance qualification

Validation may include:

• Process validation
• Cleaning validation
• Analytical-method validation
• Computerised-system validation
• HVAC qualification
• Water-system validation
• Sterilisation validation
• Aseptic-process simulation
• Hold-time studies
• Transport validation

Technical Staff Required

Staff requirements depend on products and scale.

A pharmaceutical facility may need:

• Responsible pharmacist
• Production pharmacist
• Quality-assurance manager
• Quality-control manager
• Analytical chemists
• Microbiologists
• Validation personnel
• Regulatory-affairs personnel
• Engineering personnel
• Warehouse personnel
• Maintenance technicians
• Trained production operators

Prepare:

• Organisational chart
• Job descriptions
• Qualification records
• Experience records
• Training matrix
• Initial training
• Periodic retraining
• Health and hygiene procedures

Documents Required for the Manufacturing-Licence Application

The exact checklist should be confirmed from the latest SAHPRA documents. Common supporting documents include:

Business Documents

• Completed GLF-LIC-01A
• Application cover letter
• CIPC or other ownership documents
• Company registration
• Directors’ details
• Authorised representative details
• Existing licence, for renewal or amendment
• Proof of payment

Pharmacy and Pharmacist Documents

• NDoH pharmacy-premises licence or proof of application
• Responsible pharmacist registration or SAPC case number
• SAPC certificate recording the pharmacy or case number
• SAPC certificate recording the pharmacy owner or case number

Premises Documents

• Physical address
• Local-area plan
• Site plan
• Floor plan
• Building layout
• Personnel-flow plan
• Material-flow plan
• HVAC zoning
• Warehouse layout
• Laboratory layout
• Utility diagrams

Technical Documents

• Site Master File
• Quality manual
• List of manufacturing activities
• Dosage-form list
• Product list
• Machinery list
• Laboratory-equipment list
• Technical-staff list
• Organisational chart
• Validation Master Plan
• Major SOP index
• Water-system details
• HVAC details
• Contract agreements, where applicable

SAHPRA’s published checklist specifically lists the application cover letter, proof of payment, ownership documents, NDoH premises documentation, responsible pharmacist documentation, SAPC pharmacy and owner recording, and a product list.

Application Submission

Applicants should:

1. Download the latest GLF-LIC-01A.
2. Read the current SAHPGL-LIC-01 guideline.
3. Check the current SAHPRA fee schedule.
4. Prepare the full supporting package.
5. Submit the application using SAHPRA’s current submission method.
6. Retain proof of submission.
7. Respond promptly to screening queries.
8. Submit the Site Master File through the prescribed channel.
9. Prepare for inspection.

SAHPRA may request additional information where necessary to determine compliance, quality, safety and efficacy.

SAHPRA Inspection

A SAHPRA inspection may evaluate:

• Premises
• HVAC
• Water systems
• Manufacturing equipment
• Laboratory facilities
• Warehouses
• Staff qualifications
• GMP documentation
• Data integrity
• Qualification
• Validation
• Cleaning
• Material controls
• Batch records
• Complaints
• Recalls
• Contract activities
• Self-inspection
• Computerised systems

The current South African GMP guide is SAHPGL-INSP-02 Version 10, updated April 24, 2026.

Inspection Deficiencies and CAPA

Following inspection, the company may receive observations or deficiencies.

The company should:

1. Analyse the root cause.
2. Determine the extent of the problem.
3. Prepare corrective actions.
4. Prepare preventive actions.
5. Assign responsible persons.
6. Provide realistic completion dates.
7. Submit supporting evidence.
8. Verify effectiveness.

Responses should address the deficiency rather than merely promise future compliance.

Grant of Manufacturing Licence

A licence may be issued after SAHPRA is satisfied that:

• The application is complete.
• The premises is suitable.
• Required pharmacy approvals are in place.
• The responsible pharmacist is properly registered.
• Manufacturing operations comply with GMP.
• Equipment and utilities are qualified.
• Quality systems are operational.
• Inspection deficiencies have been resolved.

The licence may contain restrictions or conditions covering approved activities and dosage forms.

Product Registration Is a Separate Requirement

A facility licence and a medicine registration are different approvals.

Manufacturing Licence

Approves the establishment and authorised manufacturing activities.

Product Registration

Approves a particular medicine based on its:

• Quality
• Safety
• Efficacy
• Formula
• Manufacturing process
• Specifications
• Stability
• Labelling
• Professional information
• Patient information

SAHPRA’s medicine-application form is used for registration, variation or renewal of human or veterinary medicinal products.

In general, medicines must be registered before they are marketed, except where a specific lawful exemption or Section 21 authorisation applies.

Product-Registration Dossier

A human-medicine dossier may include:

• Administrative information
• Active ingredient information
• Finished-product formula
• Pharmaceutical development
• Manufacturing process
• Process controls
• Specifications
• Analytical methods
• Method validation
• Container-closure system
• Stability data
• Bioequivalence data, where applicable
• Non-clinical data
• Clinical data
• Professional Information
• Patient Information Leaflet
• Labelling and packaging

The exact dossier depends on whether the product is:

• New chemical entity
• Generic medicine
• Biological medicine
• Complementary medicine
• Veterinary medicine
• Line extension
• OTC medicine

Stability Studies

Stability studies support:

• Shelf life
• Storage conditions
• Packaging suitability
• In-use period
• Reconstitution period
• Product quality throughout its shelf life

Stability chambers should be:

• Qualified
• Calibrated
• Continuously monitored
• Alarmed
• Supported by contingency arrangements

Packaging and Labelling

Packaging should protect medicines from:

• Moisture
• Light
• Oxygen
• Contamination
• Breakage
• Tampering
• Temperature

Labels and package inserts must correspond to the approved product information.

The manufacturer should have controls for:

• Artwork approval
• Version control
• Printed-material receipt
• Reconciliation
• Line clearance
• Overprinting
• Batch coding
• Destruction of obsolete material

Warehouse Requirements

Separate or controlled areas may be needed for:

• Incoming materials
• Quarantined materials
• Approved materials
• Rejected materials
• Printed packaging
• Finished-product quarantine
• Released finished products
• Returned goods
• Recalled goods
• Expired goods
• Cold-chain products
• Controlled substances

Stock should be traceable by:

• Product
• Batch
• Supplier
• Quantity
• Status
• Expiry date
• Storage condition

Contract Manufacturing

A company may use a licensed contract manufacturer rather than establishing its own factory.

Under contract manufacturing:

• The product owner controls the brand and product registration arrangement.
• The contract manufacturer carries out approved manufacturing activities.
• Responsibilities are documented in a quality agreement.
• Product and facility approvals must be maintained.
• Regulatory responsibilities remain clearly allocated.

Contract manufacturing may reduce capital investment, but it does not eliminate product-registration, quality and legal responsibilities.

Contract Testing Laboratory

A contract testing laboratory that performs regulated pharmaceutical testing may require inclusion in the relevant licensing framework.

GLF-LIC-01A specifically includes contract testing laboratories within its scope.

Responsibilities should be covered by a written agreement addressing:

• Sampling
• Test methods
• Specifications
• Investigations
• Data retention
• Change control
• Regulatory inspection
• Results approval

Import and Export Activities

A manufacturer planning to import or export should include the applicable activities in its licensing strategy.

Possible additional requirements include:

• SAHPRA import or export activity approval
• Customs registration
• Import permits
• Export documentation
• Certificates of Pharmaceutical Product
• GMP certificates
• Destination-country product registration
• Post-importation testing, where applicable

Do not assume that a domestic manufacturing licence automatically covers every import or export activity.

Licence Renewal

SAHPRA advises pharmaceutical licence holders to renew their licences every five years and to submit the renewal application at least 180 days before the existing licence expires.

Maintain a regulatory calendar covering:

• Licence expiry
• Renewal submission
• Annual retention fees
• Responsible pharmacist changes
• Ownership changes
• Product retention fees
• Inspection commitments
• CAPA deadlines

Licence Amendments and Facility Changes

Critical changes should be reviewed and, where required, approved before implementation.

Examples include:

• Change of ownership
• Change of responsible pharmacist
• Change in premises
• New manufacturing section
• New dosage form
• Major equipment change
• Major HVAC modification
• New production building
• Change in warehouse
• New import or export activity
• Contract-testing change

SAHPRA specifically reminds licence holders that critical facility changes falling under Regulation 23(7) should be approved before implementation.

Cost of Starting a Pharmaceutical Manufacturing Unit

There is no standard fixed investment.

The total cost depends on:

• Location
• Land or lease
• Factory size
• Dosage forms
• Production capacity
• Sterile or non-sterile operations
• HVAC
• Water systems
• Laboratory instruments
• Imported machinery
• Validation
• Staff
• Product development
• Registration
• Stability studies
• Working capital

Major Budget Heads

Prepare costs for:

• Business incorporation
• Land or factory lease
• Architectural and engineering design
• Construction
• HVAC
• Pharmaceutical water
• Electrical supply
• Backup generator
• Production machinery
• Packing machinery
• QC laboratory
• Stability chambers
• Warehouses
• IT systems
• Regulatory fees
• Inspection fees
• Consultants
• Technical staff
• Validation
• Raw materials
• Packaging materials
• Product registration
• Distribution
• Working capital

Sterile injectable, biological, high-potency and specialised manufacturing facilities require substantially greater investment than basic non-sterile oral or topical facilities.

Best Startup Strategy

A first-time manufacturer should consider:

1. Starting with one or two non-sterile dosage forms.
2. Selecting a limited product range.
3. Completing a detailed feasibility study.
4. Engaging the responsible pharmacist early.
5. Obtaining regulatory and pharmacy-premises guidance before construction.
6. Using an experienced pharmaceutical architect.
7. Designing for future expansion.
8. Installing scalable machinery.
9. Building quality systems before inspection.
10. Registering products in stages.

Beginning with sterile injections, biological medicines or highly potent products may expose an inexperienced company to very high technical and financial risk.

Common Mistakes to Avoid

Avoid these mistakes:

• Referring to the old Medicines Control Council instead of SAHPRA
• Registering a company and assuming manufacturing can begin
• Purchasing machinery before finalising dosage forms
• Signing a factory lease without checking zoning
• Constructing without a GMP-qualified design
• Ignoring the NDoH pharmacy-premises process
• Appointing a responsible pharmacist only on paper
• Confusing facility licensing with product registration
• Mixing pharmaceutical and medical-device licence routes
• Treating complementary medicines as unregulated products
• Underestimating HVAC and water-system costs
• Copying SOPs from another factory
• Failing to qualify equipment
• Starting commercial manufacture before approval
• Not planning stability studies
• Underestimating laboratory cost
• Making critical changes without prior approval
• Missing the licence-renewal deadline
• Ignoring working capital

Practical Manufacturing-Unit Checklist

Before applying, confirm:

• Company registered
• Product categories classified
• Dosage forms finalised
• Feasibility study completed
• Industrial site selected
• Zoning confirmed
• Responsible pharmacist appointed
• NDoH premises application submitted
• SAPC recording processes initiated
• GMP layout completed
• Facility constructed
• HVAC installed
• Water system installed
• Machinery installed
• QC laboratory operational
• Warehouses operational
• Site Master File completed
• Quality manual completed
• SOPs approved
• Equipment qualification completed
• Validation Master Plan approved
• Staff trained
• GLF-LIC-01A completed
• Fee paid
• Product list prepared
• Internal inspection completed
• SAHPRA inspection readiness confirmed

Final Answer

To start a pharmaceutical manufacturing unit in South Africa, you need an approved business structure, suitable pharmacy premises, a registered responsible pharmacist, a GMP-compliant facility and a SAHPRA manufacturing licence.

The current SAHPRA application is made using Form GLF-LIC-01A under Section 22C of the Medicines and Related Substances Act.

The practical process includes:

1. Product and dosage-form selection
2. Business registration
3. Site and premises approval
4. Responsible pharmacist appointment
5. Pharmacy and owner recording
6. GMP facility design
7. Machinery and laboratory setup
8. Quality-system implementation
9. Site Master File preparation
10. SAHPRA application
11. GMP inspection
12. Resolution of deficiencies
13. Licence grant
14. Individual product registration

A manufacturing licence alone does not permit unrestricted sale of every medicine. Each product must also follow the applicable registration or authorisation route.

Use the latest SAHPRA, NDoH and SAPC forms and guidelines because forms, fees, submission channels and technical standards may change.

Frequently Asked Questions

1. Which authority licenses pharmaceutical manufacturers in South Africa?

SAHPRA issues licences to manufacture, import or export medicines and scheduled substances.

2. Has the Medicines Control Council been replaced?

Yes. SAHPRA replaced the former Medicines Control Council regulatory structure.

3. Which application form is used?

The current manufacturer application is GLF-LIC-01A.

4. Is a responsible pharmacist required?

Yes. The licensing package requires responsible-pharmacist registration or the applicable SAPC case number.

5. Is a pharmacy-premises licence required?

The SAHPRA checklist asks for the NDoH premises licence or evidence that the application has been submitted.

6. Is SAPC recording required?

The application package includes SAPC recording of the pharmacy and pharmacy owner, or relevant case numbers.

7. Is GMP compulsory?

Yes. Manufacturers must comply with acceptable quality-assurance principles and South African GMP requirements.

8. Is a Site Master File required?

A Site Master File is an important part of the pharmaceutical facility’s licensing and inspection documentation.

9. Does the manufacturing licence register products?

No. Facility licensing and product registration are separate regulatory processes.

10. Can medical devices be manufactured under the same application?

Medical-device manufacturing follows a separate SAHPRA application route, including GLF-MD-06A.

11. Are Ayurvedic products regulated?

Yes. Ayurveda is included within South Africa’s complementary-medicines framework, and relevant establishment and product requirements apply.

12. How long is a pharmaceutical licence valid?

SAHPRA advises licence holders to renew every five years.

13. When should renewal be submitted?

The renewal should be submitted at least 180 days before the existing licence expires.

14. Can testing be outsourced?

Certain testing may be outsourced to a suitable contract laboratory under a written quality agreement, but the manufacturer remains responsible for product quality.

15. Can I manufacture products before registration?

Commercial marketing generally requires product registration or another lawful authorisation in addition to the manufacturing licence.

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