Introduction: Why Does the Change Room Procedure Matter? When it comes to pharmaceutical aseptic areas, maintaining sterility isn’t just a nice-to-have—it’s an absolute must. The change room procedure acts as the gateway between the outside world and a meticulously controlled environment. You might think, “It’s just a room where you change clothes, right?” Not exactly. It’s a process designed to […]
In sterile injectables manufacturing, maintaining cleanliness is critical to ensure the quality and safety of pharmaceutical products. While aseptic areas often receive the most attention, the proper cleaning of non-aseptic areas plays a vital role in preventing contamination and supporting overall facility hygiene. This guide provides an in-depth look into the cleaning practices, frequency, types and rotation of disinfectants, best […]
1. Introduction When it comes to manufacturing sterile injectables, there’s no room for error. Every tiny component plays a crucial role in ensuring the product’s safety and efficacy—and that includes seals and plugs. These unassuming pieces are the unsung heroes of sterility, working silently to protect the contents from contamination. But achieving that level of reliability? It all starts with […]
Finding the Root Cause and Implementing Producing high-quality pharmaceutical products is a complex and meticulous process that leaves no room for error. Amidst this complexity, finding the root cause of issues and implementing effective corrective and preventive actions (CAPA) stand out as essential pillars. These practices not only ensure regulatory compliance but also safeguard patient safety and maintain the integrity […]
Checklist for Batch Manufacturing Record (BMR) Review Audit Area Checklist Item Compliant (Yes/No) Remarks BMR and Label Issuance Issuance of BMR and label claim is proper. All pages are available and comply with the index. Manufacturing and expiry dates are correctly allotted. Dispensing Activities Dispensing is carried out on a calibrated balance. Raw Material Requisition is available. Coating Material Requisition […]
Checklist for Batch Review in Liquid Manufacturing Section Audit Point Compliance (Y/N) Remarks Issuance Issuance of BMR and label claim is proper All pages are available and comply with the index Manufacturing and expiry dates are correctly allotted Dispensing Dispensing is carried out on a calibrated balance Raw Material Requisition is available Line clearance is taken prior to all dispensing […]
Section Audit Point Compliance (Y/N) Remarks Software Management Is the list of software installed in equipment and instruments available? Are the certificates for all installed software available? Are the CDs for software available and stored properly? Are the software systems validated as per 21 CFR Part 11 requirements? Is there documentation for software lifecycle management, including installation qualification (IQ), […]
Section Audit Point Compliance (Y/N) Remarks Documentation Are all necessary and relevant documents received? Is the Certificate of Analysis (COA) of the raw material (RM) provided by the manufacturer? Does the documentation match the material details (e.g., Name, Batch No., Mfg. and Exp. Dates)? Is the material received from a vendor listed in the approved vendor list? Vehicle Inspection […]
Section Audit Point Compliance (Y/N) Remarks General Information Does the COA contain the name and address of the API manufacturer? Is the COA dated and signed by the authorized personnel of the manufacturer? Does the COA include a unique identification number or reference? Is the Certificate of Analysis issued on the manufacturer’s letterhead? Product Information Is the API name […]
A $6.2m grant from the Coalition for Epidemic Preparedness Innovations (CEPI) went to South African biotech Afrigen Biologics for leadingIFT Valley fever mRNA vaccine development. Thanks to funding from CEPI Afrigen researchers will collaborate with the International Vaccine Institute (IVI) to progress the mRNA candidate through animal trials and human safety tests leading to a Phase I clinical trial. Scientists […]
