Floor Inspection, Purpose :
Floor Inspection, The purpose of this SOP is to describe the roles, responsibilities and activities of production and QC floor inspection and IPCs check by QA personnel and to ensure Assurance with cGMP requirements.
Floor Inspection, Scope :
This procedure is applicable for cGMP observations of production and QC floor at XX Pharmaceuticals Limited (Both General and Sterile Block).
Definitions / Abbreviation:
[][]IPC : In Process Check
[][]QA : Quality Assurance
[][]QC : Quality Control
[][]OOS : Out Of Specification
[][]DT : Disintegration Time
Responsibilities:
[][]The roles and responsibility is as follows:
Quality Assurance Personnel
[][]Responsible for inspection of Production and QC floor to find out any cGMP observations.
Manager, Quality Assurance
[][]To ensure implementation of the procedure
Head of Quality Assurance
[][]Approval of SOP
Procedure:
[][]To assure Assurance with specification throughout a production process, Production Department will conduct the IPC checks following the In-process checks procedure.
[][]IPC inspectors of QA will verify the IPC data independently.
[][]The IPC specification will be mentioned in the relevant product specification and BMR & BPR.
[][]All OOS results will be investigated as per OOS results procedure.
[][]IPC inspector will verify the IPC data based on the frequency described in Annexure–I.
[][]During manufacturing of a batch, production personnel will check the IPC parameters.
[][]If a IPC data goes outside specification, production IPC checking personnel and QA IPC inspector will inform to production Executive for corrective measures.
[][]If QA IPC inspector observes that there is frequent failure of the IPC results then QA IPC inspector will notify the issue to Departmental Manager and Manager, Quality Assurance.
All IPCs will be performed by trained and certified QCOM and Production personnel. Inspection of
=>Adherence to Line clearance
=>Environmental conditions
=>Log books
=>General house keeping
=>Labelling status
=>Sampling
=>Reconciliation
=>Calibration status
=>Deviation
=>Pest controls
=>Cleaning & Contamination
=>Change Control
=>Document management
=>Adherence to maintenance schedule
Inspect GMP compliance in
=>Storage of Raw/Packaging materials/Finished packs
=>Manufacturing/packaging/cleaning operations
=>Dispensing of materials
=>Compliance with SOPs
=>Daily balance monitoring records
QA inspectors will visit the production floor daily. The inspection applies to all operations, specially The following:
=>If any unusual observation comes to the notice of area QA inspector, he will immediately communicate to the Departmental Executive. This report will be recorded in Daily IPC report format (Annexure-II).
=>This inspection report will be forwarded to Manager, Quality Assurance for further action.
=>QA inspectors will collect retention samples of finished packs from the running Secondary packaging line belts & record sampling date and quantity sampled in BPR with sign & date as per Sampling SOP.
In-Process Controls Check:
[][]QA Inspectors will independently conduct all In-process checks in addition to that done by production personnel as Procedure for In-Process Checks.
[][]QA inspectors will conduct the following IPC checks as per frequency described in Annexure–I and as a minimum at least once from every batch of product. This should be done at the start of every batch:
[][]Product: Tablets/Capsule
=>Manufacturing Stage: Encapsulation/ Compression/Coating
=>IPC Checks: Appearance, Average weight, Uniformity of weight, Hardness, Thickness, DT, RH & Temperature
=>Manufacturing Stage: Blister Packing
=>IPC Checks: Leak test, Overprinting, Cutting, RH, Temperature, Product name, Strength, Product code, Mfg & Expiry date, Price and Status label etc.
[][]Product: Powder for Suspension
=>Manufacturing Stage: Manufacturing, Filling & Packing
=>IPC Checks: Appearance, Uniformity of weight, Leak Test, RH, Temperature, Product code, Mfg & Expiry date, Overprinting, Price and Status label etc.
[][]Product: Sterile (Capsules/ Tablets)
=>Manufacturing Stage: Encapsulation/ Compression/Coating
=>IPC Checks: Appearance, Average weight, Uniformity of weight, Hardness, Thickness, DT, RH & Temperature.
=>Manufacturing Stage: Blister Packing
=>IPC Checks: Leak Test, Overprinting, Cutting, RH, Temperature, Product code, Mfg & Expiry date, Price and Status label etc.
[][]Product: Sterile (Powder for Suspension )
=>Manufacturing Stage: Manufacturing, Filling & Packing
=>IPC Checks: Appearance, Uniformity of weight, Leak Test, RH, Temperature, Product code, Mfg. & Expiry date, Overprinting, Price and Status Label etc.
[][]Product: Dialysis Fluid
=>Manufacturing Stage: Manufacturing, Filling & Packing
=>IPC Checks: A Appearance, pH, Weight, Induction Sealing, Cap Sealing, Leak Test, Temperature, Pressure
[][]QA inspectors will verify the IPC results as per specification.
[][]If any batch is completed before inspection of QA IPC inspector, then again QA IPC inspectors will verify the some critical parameters.
[][]In-process test failures must be brought to the attention of the Departmental Executive/ Manager & also Manager, Quality Assurance and appropriate action shall be taken and recorded.
[][]Any problem identified at production floor during printing or in-process checking during packaging, Problem observer immediately inform it, to his/her supervisor and if required Online Problem Notification Form (Annexure-III) to be raised by production through QA.
[][]Reference No. for Online Problem Notification will be as
PN-001/02/XX
Where-
=>PN represents Problem Notification
=>001 represents sequential number
=>02 represent Month of February
=>XX represents year of 20XX
[][]If any receiving quantity of packaging material requires replacement to run production smoothly, it shall be raised by production with Material Replacement Form (Annexure-IV) to warehouse through QA with justified reason for replacement.
[][]Reference No. for Material Replacement will be as
MR-001/02/XX
Where-
=>MR represents Material Replacement
=>001 represents sequential number
=>02 represent Month of February
=>XX represents year of 20XX
[][]The copy of raised Online Problem Notification Form should be sent to Manager, Supply Chain & Management with recommendation of Head of Quality Assurance if required.
QC Floor Inspection:
[][]QA IPC Inspector will also visit the Quality Control laboratory once daily for GLP in place and in use check.
Annexure:
Annexure-I: In-Process Checks
Annexure-II: Daily IPC Finding and Observation Report Sheet
Annexure-III: Online Problem Notification Form
Annexure-IV: Material Replacement Form