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2K views10 pagesIn Process Control in Pharmaceutical
In-process control (IPC) refers to checks performed during pharmaceutical manufacturing and packaging processes to monitor critical parameters and ensure intermediate and finished products meet specifications. IPC helps identify issues early to allow for corrective actions and prevent substandard products. It includes testing of raw materials, in-process sampling, environmental monitoring, equipment calibration, and documentation. Regular IPC is vital for maintaining quality, complying with regulations, and assuring safety and efficacy.
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100% found this document useful (1 vote)
2K views10 pagesIn Process Control in Pharmaceutical
In-process control (IPC) refers to checks performed during pharmaceutical manufacturing and packaging processes to monitor critical parameters and ensure intermediate and finished products meet specifications. IPC helps identify issues early to allow for corrective actions and prevent substandard products. It includes testing of raw materials, in-process sampling, environmental monitoring, equipment calibration, and documentation. Regular IPC is vital for maintaining quality, complying with regulations, and assuring safety and efficacy.
Uploaded by
Vinay PatelCopyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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In Process Control in
Pharmaceutical Industry
One Quality Solutions Ltd.
Email: [email protected]
Web: www.1qualitysolutions.com
What is In Process Control?
▪ In-Process Control refers to the checks performed during an
activity (it can be manufacturing or packing) in order to monitor
and if necessary to adjust the process and/or to ensure that the
intermediate or finished product conforms to its specification.
▪ The control of equipment and environment may also be regarded
as the part of in process control.
▪ In process checks are vital as manufacturing activity itself and
the same shall be performed at regular intervals. Frequency of
the in process checks need to be realistic.
▪ The objective of in process checks are both quality control and
process control.
One Quality Solutions Ltd. Email: [email protected] Web: www.1qualitysolutions.com
? Why IPC checks should be done ?
▪ The in-process control is the checks made during the course of manufacture which aims to
ensure that product will comply with specifications. Thus, quality is built into the product.
▪ In process quality check is designed to provide early warning for quality or other problems
arising during production.
▪ In other words it is intended to provide a snapshot of the quality of the product
manufactured at the factory.
▪ By carrying out in process checks one can assure the product quality.
One Quality Solutions Ltd. Email: [email protected] Web: www.1qualitysolutions.com
●
How to make IPC more effective?
People: Are the right people engaged?
?
● Training: Have all been properly trained?
● Environment: Is the environment acceptable?
● Process: Are the process validation?
● Equipment: Is the equipment validated and maintained?
● Management: Does the manufacturing section takes IPC seriously?
One Quality Solutions Ltd. Email: [email protected] Web: www.1qualitysolutions.com
? Others:
How to make IPC more effective?
• Implementation of GMP.
• Taking a balanced decision.
• Elimination of communication gap.
• Proper checking system for all critical parameters.
• Follow up the manufacturing instructions.
• Remedial actions against recurrence of a problem.
• Better understanding between production and QA staff.
One Quality Solutions Ltd. Email: [email protected] Web: www.1qualitysolutions.com
In Process Checks During Manufacturing
• Ensure correct materials are brought in for manufacturing activity.
• Check sieve integrity.
• Ensure manufacturing is carried out as per the instruction given in the BMR.
• Ensure operators are wearing hand gloves and nose mask during all stages of manufacturing.
• Verify the records for online entries.
• Environmental Monitoring.
• Check & verify equipment parameters like temperature, drying time etc.
• Checking process parameters like Appearance, Avg. weight, Group Weight, Hardness, friability,DT etc.
• Yield verification.
• Checking the weights of in process materials.
• Checking labeling status of the quarantine materials.
• Ensure doors are closed during processing.
One Quality Solutions Ltd. Email: [email protected] Web: www.1qualitysolutions.com
In Process Checks During Packing
• Ensure Name, Strength, Volume & quantity is correct.
• Check the status labels on equipment, area & in process container.
• Over printing quality.
• Batch coding details on primary & secondary pack (B.No.,Mfg.,Exp., M.R.P.etc.).
• Text matter on the ptd. foil & carton.
• Verification forming & sealing temperature.
• Ensure blisters are free from knurling defects.
• Leak Test.
• Pharmacopeial status of the material used is correct.
• Mfg. License number is printed correctly.
• Preprinted packing materials provide mandatory information & legal status.
• Storage conditions details available in the packaging materials.
One Quality Solutions Ltd. Email: [email protected] Web: www.1qualitysolutions.com
In Process Checks During Packing
• Directions for use details available in the packaging materials.
• Ensure warnings against wrong administration is provided in the pack.
• Storage condition is same all printed packing Materials.
• Ensure correct leaflet is used for the product.
• Verify printed matter on the outer cartons and shippers.
• Ensure checkers are performing their activity in a proper way.
• Verify blisters & strips for alignment defects & empty pockets.
• Ensure doors are closed during processing.
• Verify the records for online entries.
• Environmental Monitoring.
• Sampling
One Quality Solutions Ltd. Email: [email protected] Web: www.1qualitysolutions.com
SUMMARY
✔ In-process control (IPC) plays a vital role in maintaining the quality and consistency of
pharmaceutical products during their manufacturing process.
✔ IPC involves conducting tests, inspections, and monitoring at various stages to ensure that
critical parameters meet the predefined standards.
✔ It helps to identify deviations or abnormalities early on, allowing for timely corrective actions
and preventing the production of substandard or unsafe products.
✔ IPC includes activities such as raw material testing, in-process sampling, environmental
monitoring, equipment calibration, and documentation.
✔ By implementing robust IPC measures, pharmaceutical companies can enhance product quality,
comply with regulatory requirements, and ensure the safety and efficacy of the medications
they produce.
One Quality Solutions Ltd. Email: [email protected] Web: www.1qualitysolutions.com
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