What is the ISO standard for pharmaceutical industry?
ISO 9001 is the one standard within the ISO 9000 system that defines the requirements for a quality management system and helps businesses and organizations to be more efficient, improve customer satisfaction, and specifically for pharmaceutical manufacturers, to help improve patient safety.
What is ps9000?
• PS 9000 is an application standard written by the PQG for suppliers of. pharmaceutical packaging materials that integrates ISO 9001 and ISO. 9004 together with additional Good Manufacturing Practices (GMP)
Are pharmaceutical companies ISO certified?
Getting ISO 9001:2015 certificate is an added value to pharma companies to ease import and export potential of quality products. Following ISO 14001:2004 standards in pharma companies indicate that the companies carry out the processes in such a way that lesser pollutants are produced (Environmental Management System).
What is the difference between GMP and ISO?
GMP stands for Good Manufacturing Practices, and refers to a system of manufacturing that guarantees reproducibility of product quality to set specifications. ISO stands for International Organization for Standardization, which offers a standard for operating a firm from management through manufacturing.
Why line clearance is important in pharma?
Line clearance is useful to ensure the cleanliness of the manufacturing area. It is good manufacturing practices requirement to prevent the mix up and cross contamination in pharmaceutical products.
How the printed packaging material is disposed off in pharmaceutical industry?
5.2 POLYTHENE BAGS /NYLON BAGS /PAPER BAGS 1 Collect all the bags, after consuming the material, deface the label and printed matter with the permanent marker pen or indelible ink so that the printed matter is not readable. 2 After defacing the label, send the empty bags to the scrap yard for further disposal.
What is ISO 9001 specifically?
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
What is the difference between DMF and CEP?
Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
What is GMP line clearance?
Line clearance is a structured procedure for ensuring that the equipment and work area are free of products, documents and materials from the previous process that are not required for the next scheduled process, and that the equipment is clean and ready for the next scheduled process.
How many types of line clearance are there?
Packaging Area/Line Clearance during batch/product change over
|PACKAGING AREA / LINE CLEARANCE CHECKLIST – TYPE C|
|Previous Product :|
|1.||Area cleaned Type C board displayed.|
|2.||Packing equipment cleaned as per Type B/C cleaning procedure.|
|3.||Packing area cleaning checklist Type – C filled by Officer -Production.|
How is the rejected material handled?
5.1 Material reject due to received in damaged condition 2 If the material is rejected by Q.A. department after inspection, Store person shall transfer the material in the rejected room under lock & key and fill the material discrepancy report and inform to Purchase department.