In today’s world of pharmaceutical serialization where we have dozens of different regulations and laws pertaining to pharmaceutical and medical device serialization across the globe, the Quality Person (QP), Quality Assurance (QA) or Quality Control (QC) team in the pharmaceutical industry has to put in a lot of efforts to validate the entire system and ensure that all the process, procedure, and method is working correctly and would consistently lead to the expected results.

Looking at the level of quality standards in the pharmaceutical industry, the QA/QP/QC expert role is extremely important across the whole process to minimize the risks and ensure proper alignment for the selection, implementation, and maintenance of quality system with the authorities’ requirements.

Key factors to consider while validating the system

The entire process of system validation is considered to be one of the most complicated steps in the pharmaceutical industry and there are 3 key factors which are mostly affected:

1. Schedule – System implementation requires installation and qualification of a data center, backup and restore processes, server installations and establishing connections with various interface followed by testing and creation of documented evidence to assure proper functioning of the system which takes a long time to complete.

2. Budget – System validation can be an expensive and recurring process if the system governance procedures have not been correctly established or the team is not experienced. To minimize the validation expenses, the risk-based approaches should be used or partnering with your vendors can be another way to keep the validation costs in check.

3. Resources – Validation can be a large burden on internal resources if the responsibility is not properly shared or managed within the teams or with external consultants/partners.

Following the industry standard is a must

System validation is an ongoing process which requires system governance to determine how the system will be regulated, monitored, and managed. In addition, proper procedures need to be in place for system administration, change control, new system or functionality releases and other items related to the system to ensure that the validation is maintained. The validation should be performed according to the pharmaceutical industry’s regulation such as GAMP 5, FDA’S 21 CFR PART 11, EU GMP ANNEX 11.

Most pharmaceutical companies follow the GAMP®5 V-Model (Good Automated Manufacturing Practice V-Model) to validate their system as it meets the requirements of the industry regulators. This model is used to define the relationship between requirements and specifications and the verification and testing performed on them.

Necessary validation documents must be in place

To reduce the effort of a QA, QP, QC, one can ask their system vendor/partner to provide them with a detailed set of quality documents as per the current industry standards such as GAMP 5 guidelines, GxP and FDA regulations/recommendations. The vendor offering the validation services must go through the unique requirements and processes of the company and include the following deliverables:

  • Validation Master & Site Plans
  • Test cases separately for each regulation
  • IQ, OQ & PQ validation report
  • Validation summary report
  • Risk Analysis & Mitigation Plan
  • Traceability Matrix
  • Production Approval Plan
  • Impact assessment analysis reports for any new updates/versions

Apart from these, the vendor should also offer the services to review the internal & external documents of the organization, like the SOPs, training records, change management, quality plan, internal risk assessment, vendor functional and design specifications, documents for FAT (Factory Acceptance Test) & SAT (Site Acceptance Test), etc. and perform gap analysis to analyze the missing documents and create them wherever required.

All the documents should be constantly updated to match the quality system requirements and kept accessible for any local documentary request from the authorities.

How can CosmoTrace help?

As Serialization Consulting Experts, our focus is on delivering the absolute best serialization support by offering long-term serialization and sustainability strategies and providing forward-thinking industry solutions.

Our Validation Package consists of various levels of tests, checklists, and reports, and can be tailored to your needs to ensure no information gaps arise. Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in Product Serialization, Pharmaceutical Supply Chains, Life Sciences and Brand Integrity.

CosmoTrace’s commitment is towards providing focused operational excellence and outstanding, quality service. We are driven to perform consistently by focusing on our core values:

  • Integrity
  • Quality
  • Customer Service
  • Accountability

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