Minimum Requirements to Establish a Pharmaceutical Manufacturing Plant

PREMISES

The facility should be located in a pollution-free area. The buildings should be compliant with good manufacturing practices (GMP) requirements as per the Regulatory GMP Guideline.

SPACE REQUIRED

At a minimum, the manufacturing unit should have adequate space for:

1. Receiving and storing of raw materials

• Adequate space for receiving and storage of raw materials.
• Proper temperature and humidity controls for specific materials.
• Secure storage areas to prevent unauthorized access.
• Equipment for material handling, such as forklifts or pallet jacks.
• Adequate labeling and identification systems for efficient tracking.

2. Production areas

• Sufficient space for production equipment, personnel, and material movement.
• Proper HVAC (Heating, Ventilation, and Air Conditioning) systems to maintain appropriate temperature, humidity, and air quality.
• Adequate utilities such as water, electricity, and compressed air.
• Dedicated space for in-process quality control activities.
• Designated areas for different manufacturing processes (e.g., formulation, mixing, filling, packaging).

3. Quality Control section

• Dedicated space for quality control activities.
• Equipment for testing and analysis, such as analytical balances, pH meters, HPLC, UV, IR, GC, and microbiological testing equipment.
• Adequate storage for reference standards and control samples.
• Dedicated space for oven, muffle furnace, and handling of flammable solvent.
• Trained and qualified personnel to perform quality control tests and inspections.

4. Quarantine area

• Isolated area to store incoming materials or finished products until quality testing is performed.
• Segregated from other production areas to prevent cross-contamination.
• Properly labeled and identified to distinguish quarantined items from approved materials or products.
• Controlled access and restricted entry for authorized personnel only.
• Suitable temperature and humidity conditions for the stored items.

5. Finished goods store

• Sufficient storage space for finished products.
• Adequate shelving or pallet racks to organize and store products.
• Temperature and humidity controls, if required for specific products.
• Proper labeling and identification of stored products.
• Security measures to prevent theft or unauthorized access.

6. Rejected goods store

• Designated area for storing rejected or non-conforming materials or products.
• Segregated from approved materials or products to prevent mixing.
• Adequate labeling and identification of rejected items.
• Secure storage to prevent accidental use or disposal.
• Controlled access and restricted entry for authorized personnel only.

MINIMUM SPACE FOR SPECIFIC PRODUCTION AREAS

1. External preparation

• A minimum of 30 square meters is required for basic installation and 10 square meters for ancillary area. The formulation of external preparations and internal preparations should be separate to avoid contamination.

2. Liquid dosage forms

• For liquid dosage forms like syrups and suspensions, a minimum area of 30 square meters is required for the basic installation of machines and 10 square meters for the ancillary area.

3. Solid dosage forms

• Production of solid dosage forms like tablets, capsules, and powders requires more area for machinery installation and ancillary.
• The tablet sections require a minimum of 60 square meters for basic installation and 20 square meters for ancillary for uncoated tablets. If a coating section is required, then it should be separate from other sections having a minimum of 30 square meters for basic installation and 10 square meters for the ancillary area.
• Capsule sections require a minimum of 25 square meters for basic installation and 10 square meters for ancillary.
• The powder section requires a minimum of 30 square meters for basic installation and 10 square meters for ancillary.

4. Parenteral preparations

• The ophthalmic preparations section is a sensitive section like the parenteral section. The section should be in a separate building or separately placed from other sections mentioned above. Fully air-locked, sterile, and non-contaminated air is required for ophthalmic preparations. The minimum area required for an ophthalmic section is 25 square meters and the ancillary area is 10 square meters.
• The parenteral sections for manufacturing ampoules and vials for injection are of two types, dry parenteral preparations like a dry powder for injection and the second is liquid injection. It is the most sensitive section in a pharmaceutical manufacturing unit. It should be in a separate building and dry powder should also be separate from the liquid section. The area required may change according to whether they are large-volume parenteral or small-volume parenteral. The minimum area required for a parenteral section is 150 square meters for basic installation and 100 square meters for ancillary activities.

PERSONNEL REQUIREMENTS

Licensing of authorized/qualified persons for the supervision of manufacturing operations and release of products for sale

1. Background

• It is the mandate of regulations to ensure that medicines available on the market are safe, efficacious, and of acceptable quality. This implies that there are adequate controls from point of all aspects related to manufacturing the products to release, supply chain, and when the product is placed on the market.
• With respect to the manufacturing of products, this mandate is promoted by ensuring competent supervision of manufacturing processes and the release of products to the market. Therefore, each manufacturing site shall be required to have an Authorized/Qualified person.

2. Role of an Authorized/ Qualified Person

• Supervise the entire manufacturing process from materials management to packed products for sale and ensure that manufacturing processes follow the marketing authorization and current global best practices of manufacturing for all products.
• Perform the quality function of releasing finished products to the market

Note: The operational roles may be delegated to other competent persons in the organization under defined circumstances, but the responsibilities remain on the licensed person.

SPECIFIC GOOD MANUFACTURING PRACTICE GUIDELINES

GMP Inspection Guidelines

NB: The reference guideline documents listed below are the current WHO guidelines and may be updated from time to time by the WHO. The latest published WHO guidelines must be used for each system, even before the review period of this guideline.

FACILITY DESIGN

The manufacturer should be located at a site where there will be no risk to the community.

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