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.
Specify the MOC of the water storage tank (Both PW & WFI) and its pipe line.
Pipeline and storage tank should be made with SS 316
It can be verify with molybdenum test.
SOP FOR MOLYBDENUM TEST should be available.
Specify weather storage tank for WFI is steam jacketed.
Water storage tank should be double jacketed so sanitization and water temperature can be maintain.
Specify whether water system validation/qualification has been carried out as per protocol and reports have been prepared and maintained.
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 should contain minimum following requirement:
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 should contain minimum following requirement:
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.
Please specify whether Phase 1, Phase 2 and Phase 3 studies carried as part of PQ stages?
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.
Phase 1 should contain the following things:
- 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.
PHASE 2: should contain the following things:
- 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.
PHASE 3: should contain the following things:
- weekly sampling records are available of every usage point for a one-year period.
Specify the source of raw water and give details of treatment processes, sampling points, distribution, and storage system for raw and purified water. Verify whether the Raw Water holding tank was sanitized as per specified SOP.
- 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/