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.
Verify whether a current drawing of the water system showing all equipment in the system from inlet to the points of use is available.
Drawing of the water system should be available.
P&I diagram of water system should be available.
Drawing of water system should cover all part of water system.
Pipeline and storage tank should be made with SS 316
It can be verify with molybdenum test.
SOP FOR MOLYBDENUM TEST should be available.
Water storage tank should be double jacketed so sanitization and water temperature can be maintain.
water system qualification (IQ, OQ and PQ) should be available.
Phase I PQ should be completed within 14 days.
Phase II of PQ should be completed within 14 days.
Phase III will be start after after completation of Phase II and it can be continue till 1 year.
Purified water can be use during phase III qualification.
IQ protocol includes at least :
- facility review,
- equipment specification vs. design,
- welding roughness testing on pipelines,
- absence of dead points / section in the pipelines, pipe and tank passivation,
- drawings,
- SOP for operations, cleaning, sanitation, maintenance and calibration of gadgets.
- Its report includes Conclusion / Summary, Data tables, Results, Conclusions, Protocol reference, Revision and approval signatures.
OQ protocol includes at least System :
- production capacity (L/min),
- Flow type and water rate,
- Valve operation,
- Alarm system operation and Controls operation
- Its report includes Conclusion / Summary, operations performed Data tables, Results, Conclusions, Protocol reference, Revision and approval signatures.
water system qualification (IQ, OQ and PQ) should be available.
Phase I PQ should be completed within 14 days.
Phase II of PQ should be completed within 14 days.
Phase III will be start after after completation of Phase II and it can be continue till 1 year.
Purified water can be use during phase III qualification.
- The operations parameters, cleaning and sanitation procedures & frequencies defined.
- Daily sampling records for every pre-treatment point and usage point for a period of 2 to 4 weeks maintained and SOP’s prepared.
- Daily sampling records for every pre-treatment point and usage point for a period of 4 to 5 weeks after Phase 1 maintained and reviewed.
- weekly sampling records are available of every usage point for a one-year period.
- Source of raw water should be specify.
- Water treatment process should be available.
- Following SOPs should be available:
PROCEDURE FOR CALIBRATION OF DOSING PUMPS
PROCEDURE FOR CALIBRATION OF DOSING PUMPS NaOCl, SMBS, ANTISCALENT AND NaOH
PREPARATION OF SODIUM HYPOCHLORITE, SMBS, ANTISCALENT AND SODIUM HYDROXIDE SOLUTIONS
Click the link for Part 1
https://pharmaguidehub.com/risk-based-joint-inspection-part-1/
Click the link for Part 2
https://pharmaguidehub.com/risk-based-joint-inspection-part-2/
