cleaning validation for medical devices

Choosing the Right Packaging System for 2–8°C, CRT, or Frozen

Choosing the Right Packaging System for 2–8°C, CRT, or Frozen Choosing the Right Packaging System for 2–8°C, CRT, or Frozen In the pharmaceutical and biotech industries, ensuring the integrity of products during transportation is crucial. This involves a detailed validation…

Barcode and Serialization Label Validation in Regulated Markets

Barcode and Serialization Label Validation in Regulated Markets Barcode and Serialization Label Validation in Regulated Markets In the competitive landscape of the pharmaceutical and biologics industry, ensuring that your products adhere to the highest regulatory standards is paramount. This validation…

Performance Qualification (PQ): Cleanroom Recovery, Velocity, and Monitoring

Performance Qualification (PQ): Cleanroom Recovery, Velocity, and Monitoring Performance Qualification (PQ): Cleanroom Recovery, Velocity, and Monitoring Cleaning validation is a critical component of compliant operations in the pharmaceutical and medical device sectors. To ensure that these environments meet regulatory expectations,…

Report Approval Checklist for QA Reviewers

Report Approval Checklist for QA Reviewers Report Approval Checklist for QA Reviewers The pharmaceutical and biologics sectors are tightly regulated environments that necessitate stringent quality assurance (QA) processes. One critical aspect of these processes is the documentation required for effective…

How to Prioritize Validation Projects Within a VMP

How to Prioritize Validation Projects Within a VMP How to Prioritize Validation Projects Within a VMP In the highly regulated pharmaceutical and medical device industries, a Validation Master Plan (VMP) serves as a critical document that ensures all validation efforts…

Compliance Requirements for Electronic Records in GMP Systems

Compliance Requirements for Electronic Records in GMP Systems Compliance Requirements for Electronic Records in GMP Systems In the pharmaceutical and biologics industries, ensuring compliance with regulatory guidance is critical, particularly when it comes to the use of electronic records. This…

What to Include in a Legacy Equipment Qualification Protocol

What to Include in a Legacy Equipment Qualification Protocol What to Include in a Legacy Equipment Qualification Protocol In the pharmaceutical and biotech industries, the qualification of legacy equipment can present unique challenges, particularly in the context of cleaning validation…

PPQ Sampling Strategy: How to Justify Sample Size

PPQ Sampling Strategy: How to Justify Sample Size PPQ Sampling Strategy: How to Justify Sample Size The Process Performance Qualification (PPQ) phase in the pharmaceutical validation lifecycle is crucial for ensuring that a manufacturing process is capable of consistently delivering…