GxP Temperature Q&V
Compliance you can trust
Qualification & Validation services offer you the peace of mind that projects are carried out to the required standards and result in independent documents that support your regulatory requirements.
Validation & Qualification
Laboratory & Manufacturing
Biomap’s Qualification & Validation services offer you the peace of mind that projects are carried out to the required standards and result in independent documents that support your regulatory requirements.
We understand that although a necessary process and a regulatory requirement, you want the work to be carried out as efficiently as possible with minimal impact on your daily operation.
Projects can be standalone to meet the expectations of individual requirements or can also include VMPs (Validation Master Plans) and various Risk Assessment options.
Your Storage & Distribution
- Goods In, Waiting /Standing Areas, WIP, Goods Out. Walk in Cold Stores, Freezers & Warehouse
- Temperature conditions, product flow, security / access control
- Environmental Monitoring Solution, Temperature & RH monitoring
- HVAC Validation
- Packaging Qualification
- Vehicle Qualification
Your Research & Manufacturing Validation
- Fridges and Freezers, ULT
- Temperature conditions,security / access control
- Environmental Monitoring Solution
- LN2 storage, Control Rate Freezers and Dewars
- Autoclave Validation
- Incubator and Oven Validation
- Stability Chambers Validation
- Stability Chambers Environmental Monitoring Solutions.
Other Validation Services
- VMPS
- GMP Training Courses
- GMP Audits and Pre-Inspection Preparation
- QMS Gap Analysis and Improvement
Definition of IQ,OQ,PQ
Installation Qualification (IQ)
Verification of the correct installation of components, instrumentation, equipment, pipe work and services against the engineering drawings and specifications; verification of the correct installation against pre-defined criteria
Performance Qualification (PQ)
Should include tests, using production materials, qualified substitutes or simulated product proven to have equivalent behaviour under normal operating conditions with worst case batch sizes.
Operational Qualification (OQ)
OQ normally follows IQ but depending on the complexity of the equipment, it may be performed as a combined Installation/Operation Qualification (IOQ).
OQ should include…… tests that have been developed from the knowledge of processes, systems and equipment to ensure the system is operating as designed (EU GMP, Annex 15: Qualification and Validation)
Performance Verification (PV)
is verification of the performance of a process or a system over a defined period of time to demonstrate its stability and ability to perform as per specification.
Personal Service
Biomap understands that each case requires a different solution. We focus on regulations but ensure that we take into account your individual requirements, no matter how much support you need.
Why Choose Biomap
Biomap has a team of expert consultants and engineers at its disposal with over 50 years’ experience, including qualified RPs and QPs to give you confidence that their advice is accurate and in line with the current regulatory expectations and best practices by the industry. Your Project will be steered by Biomap Technical Advisor, Afshin Hosseiny.
Interpretation to the EU GDP Guidelines Pharmaceutical Quality Group Monograph N.4 Biomap was a key contributor to the new Good Distribution Practice Guidance on Interpretation and Implementation, created by the Pharmaceutical Quality Group (PQG) and European Compliance Academy (ECA) Biomap contributed to ‘Chapter 3 Premises and Equipment‘ & ‘Chapter 9 Transportation’
– the full monograph was published in 2018.
Benefits of an Integrated Solution
All Qualification & Validation services are carried out by our team of experts, and with the additional options of things like consultancy services (GDP compliance assessment, training, audit and pre inspection services), monitoring systems and calibration services, there is no need to go through multiple third parties,
Biomap can manage and supply these tailored packages centrally, cutting project lead times and reducing cost.
About Biomap
Biomap is a specialist vendor of services and solutions for the Pharmaceutical and Biotech industries. Offering Qualification and Validation Services and products, in the areas of Shipping and Storage of Pharmaceutical and Temperature Sensitive products including: Temperature Mapping, Route Qualification, Vehicle Qualification, Monitoring Solutions, QMS development, WDA Application, Inspection preparation and Audits.
All products and services have been developed to support clients with regulatory demands from the EU, MHRA, FDA, , HPRA, PDA, USP and WHO, while offering quality assurance in accordance with ISO 9001:2015. Biomap’s services gives you the assurance of compliance to ensure optimum conditions for your Pharmaceutical and Temperature Sensitive products, while earning a reputation for reliance and dependability within the industry.
