The world of Life sciences is moving towards procedural standardization, risk-based methodology, quality by design (QbD) and common control framework. However, Standard Operating Procedures (SOP) writing and SOP review may sometimes, require organizations to invest a lot of time and money to research global legislations and to perennially update the systems. In such scenarios, organizations lookup for expert SOP writing services and SOP review services.

SOP Review Services

While expanding businesses to newer markets, Life sciences organizations are required to develop new SOPs based on the regional Regulatory requirements or should update/upgrade the existing processes to align them with new demands. But prior to SOP development, it is indeed the right approach to identify the gap between processes and remediate them accordingly.

GAMP Services is experienced in a range of projects on SOP review services. The simplest of the service offering is to review existing SOPs for accuracy and providing gap analysis reports to complex projects, which involve SOP review and remediation resulting in SOP standardization, rationalization or optimization.

SOP Standardization

As the business grows, the standards to be followed or adhered to will also increase. There will be times when a customer falls under so many standards and regulations to follow, which may include SOP for safety in the pharmaceutical industry. In such scenarios, maintaining and following different streams of SOPs for each standard will double up the procedural complexities for companies. The need of the hour is to unify or standardize the SOPs.

Remote Validation Services

While traditional validation services are completed onsite, GAMP services now offer Remote Validation Services.

Preparation of validation Documents and Review of Testing and documents as mention below

  • Validation plan
  • Risk assessment
  • User and functional requirements specification (UFRS)
  • System design and configuration specification
  • Validation test plan
  • IQ/OQ/PQ test cases and objective evidence
  • Traceability matrix
  • Part 11 compliance assessment
  • Validation summary report
  • Vendor audit report