Risk Based Joint Inspection Part 2

Pharmaceutical building and premises require meticulous design and construction. Key considerations include controlled environments for manufacturing and storage, preventing contamination and ensuring product integrity. HVAC systems maintain precise temperature and humidity. Cleanroom classifications dictate air particle levels. Material flow minimizes cross-contamination, with separate areas for raw materials, production, and packaging. Security measures protect high-value materials and intellectual property. Waste management systems handle hazardous materials safely. Regulatory compliance, including GMP (Good Manufacturing Practice) standards, is paramount, demanding rigorous documentation and validation throughout the facility’s lifecycle.

Building and premises: –

Specify whether the whole facility is separated, dedicated and is not a part of any other non-drug facility.:

• Any non drug facility like food should not be operate in facility.

Specify whether the surroundings of the manufacturing area is clean and as per the SOP prescribed in this regard. (Mention the SOP nos.)

Following SOP is needed.

SOP Link: CLEANING AND SANITIZATION IN PHARMACEUTICAL INDUSTRY

Describe the pest, insects, birds and rodents control system followed in the premises. Specify pest control schedule- area wise, along with materials and methods used.

Following SOP is needed.

SOP Link: RODENT AND PEST CONTROL IN FACTORY PREMISES

Following SOP is needed.

SOP Link: Building Maintenance

Specify the lux level maintained in various parts of the premise (Storage area, manufacturing area specially visual inspection, Laboratory areas etc.).

• Light should be sufficient and lux level should be within acceptance criteria (Limit of lux level for core area NLT 1000 lux and for other area NLT 500 lux

Following SOP is needed.

SOP Link: Building Maintenance

Specify the air handling system used in various areas i.e. stores, production, packing, QC areas. :

• Specific AHU system should be available in area.

Following SOPs are needed.

SOPs Link:

OPERATING OF AIR HANDLING UNIT

AHU PARAMETER MONITORING

PREVENTIVE MAINTENANCE CHECK LIST OF AHU (Air Handling Unit)

PROCEDURE FOR AHU ON/OFF REQUEST

Specify drainage system which prevents back flow and entry of insects and rodents into the premises. Specify number and location of drains installed.

• Numbering of Drain system should be available.
• GMP drain system should be available.
• Drainage layout should be available.

Following SOPs are needed.

SOPs Link:

CLEANING AND DISINFECTION OF PROCESS AREA DRAINS IN PHARMA

Specify the position of rest and refreshment rooms and mention whether they are separated and not leading directly to the manufacturing and warehouse areas.

• Seperate rest room and refreshment room should be available.
• Rest room and refreshment room should be seperate from manufacturing and warehouse area.
• Rest room and refreshment room should not contaminate to manufacturing and warehouse area.

Are there general change rooms in plant? specify number of washing station & toilets provided for number of users.

• A change room should be available in plant.
• For 25 person a toilet should be available.

Specify whether primary clean garments are provided for each personnel entering the factory premises.

• Clean garment should be available in premises.
• Cleaning frequency garmants should be define in SOP.
• Following SOPs are needed.
• SOPs Link:

LAUNDERING, ISSUE AND RETURN OF UNIFORMS IN PHARMA

SOP FOR HANDLING OF LINEN

Is there in-house general laundry for garment washing / cleaning? If not, how garment washing is carried out and monitored.

• Linen should wash in laundry.
• If in house laundry is not available then it should wash with external laundry.
• External laundry agreement should be available.
• Laundry should be audited at define frequency.
• Following SOPs are needed.
• SOPs Link:

SOP FOR CLEANING OF GARMENT WASHING MACHINE

LAUNDERING, ISSUE AND RETURN OF UNIFORMS IN PHARMA

Whether change room facilities separated for both sexes.

• Seperate change room should be available for male and female personel.

Whether maintenance workshop is separated and away from production.

• Engineering maintainence workshop should be seperate from manufacturing facility so any kind of contamination can be avoided.

Is the men & material movement inside the factory premises, observed & checked through security system.

• Man and material should be inspected at security so any objectionable things and unauthorized personal entry can be avoided.
• Following SOPs are needed.
• SOPs Link:

MATERIAL ENTRY AND EXIT AT SECURITY GATE

CHARGE HANDOVER AND TAKE OVER OF SECURITY PERSONNEL

Is CCTV available to control the Entry & Exit from Factory premises?

• If CCTV is available then it should be monitor at defined frequency so any suspecious activity can be avoided.
• CCTV review log book should be available so review record can be maintain.

Is there a system for identifying persons visiting the factory? How?

• Person should contain a ID card so employee can be identified.
• For the visiting of Visitor a Visitor card should be available.
• Following SOPs are needed.
• SOPs Link:

ENTRY / EXIT & GOWNING / DE-GOWNING PROCEDURE FOR STAFF, OPERATORS WORKERS & VISITOR TO THE PLANT

What is the precautionary activity taken for the movement of carriers i.e., vehicles?

• Only authorized vehicle should be accessible in premises.
• Vehicle should be inspected at gate.
• Driver should contain a valid driving licence.
• Speed limit of vehicle should be display in premises.
• Vehicle entry and exit record should be maintain at security.
• Following SOPs are needed.
• SOPs Link:

MATERIAL ENTRY AND EXIT AT SECURITY GATE

Click the link for Part 1
https://pharmaguidehub.com/risk-based-joint-inspection-part-1/