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: –

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

Following SOP is needed.

SOP Link: CLEANING AND SANITIZATION IN PHARMACEUTICAL INDUSTRY

Following SOP is needed.

SOP Link: RODENT AND PEST CONTROL IN FACTORY PREMISES

Following SOP is needed.

SOP Link: Building Maintenance

• 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

• 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

• 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

• 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.

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

• 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

• 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

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

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

• 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

• 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.

• 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

• 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/