Manufacturing Trend Analysis, Purpose:
Manufacturing Trend Analysis, the purpose of this SOP is to define a procedure for trending of manufacturing data and to ensure that management reviews the trends and takes appropriate action.
Manufacturing Trend Analysis, Scope:
This procedure is applicable for all products manufactured at general block and are analyzed in Quality Control and Microbiology Laboratory of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]QC: Quality Control.
Responsibilities:
[][]The roles and responsibility is as follows:
[][]Executive/Executive, QC & Microbiology
[][]To ensure that the instructions of this procedure are correctly followed.
[][]To maintain the records properly as per SOP.
Manager, Quality Control
[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[][]To ensure effective assessment of trend analysis of Product.
[][]Take correction action to prevent reoccurrence.
Head of Quality Assurance
[][]Approval of the SOP.
[][]Review all trend analysis to take appropriate action.
[][]To ensure the overall implementation of the SOP.
Procedure:
[][]Manager, Quality control will issue the ‘Finished Product Trend Card’ (Annexure-I) by making entry in the ‘Trend Card Issue Register’ (Annexure-II)
[][]QC Executive will make entry in ‘Finished Product Trend Card’ and MS Excel format at the time of report submission.
Trend the following key parameters by QC Executive taken from IPC data:
Tablet:
[][]Disintegration Test
[][]Average weight
Capsule:
[][]Disintegration Test
[][]Filled weight
Powder for suspension:
[][]Filled weight
[][]Trend the following key parameters by QC Executive taken from analytical data:
Tablet:
[][]Assay (Active content)
[][]Dissolution Test (if applicable)
Capsule:
[][]Assay(Active content)
[][]Moisture content
[][]Dissolution Test (if applicable)
Powder for suspension:
[][]Assay (Active content)
[][]Moisture content
[][]Dissolution Test (if applicable)
[][]Quality Control Manager will review the trend at the time of report approval.
[][]If there are any atypical findings that indicate potential quality or performance issues, then follow the below instruction:
[][]Carry out an immediate laboratory investigation as per procedure for out of specifications. But this action will not prevent from releasing the batch to commercial.
[][]If the laboratory investigation indicates that there is no laboratory error, then it must be reported to AGM, Quality Assurance to conduct an investigation and take action to bring the situation in control.
[][]Preserve all the data securely for Periodic Product Review.
List of Annexure:
Annexure-I: Finished Product Trend Card
Annexure-II: Trend Card Issue Register