Metrology Department
We are dedicated to handle your equipment with great care using our innovative technology and scientific knowledge. Our engineers are certified and trained according to the ISO and GxP requirements including GLP & GMP. We are in compliance with all federal agencies that your laboratory or institution may have to abide by such as FDA, EPA, and OSHA.
Diagnostics
1. Any initial MPG service starts with an Instrument Health Check to acquaint our team with your instrument (in-person service only).
2. MPG will provide their expertise in identifying any disfunction or abnormality that may interfere with proper instrumentation operation and performance; we may also follow up with repairs if necessary. This service may be rendered by phone/email or in-person based on the severity of your needs, client request, and MPG recommendations.
3. Tech Support
Qualifications (IQ/OQ/PQ)
If you desire to add more/new or relocate equipment whether throughout your GMP/GLP facility or a new facility, or after audits and even certain repairs, based on the regulations in USP 1058, the equipment would have to be validated and/or qualified through the qualification steps.
Validating the software and hardware as needed or just qualifying the hardware will sustain your laboratory accreditations, and allow your equipment to function as the manufacturer or third party seller intended based on industrial and federal regulations.
Test types:
1. Installation (IQ) - placed and activated in the right space and with the proper connections following manufacturer's instructions, including documented verification that ensure correct and complete install based on industry standards, client requirements, and federal regulations.
2. Operation (OQ) - verify functions, commands, and interrelated modules/parts' communication with documented verification of system's components, and how consistent the system is and works within the limits and tolerances it supports, based on manufacturer's and client's requirements, industry and federal standards.
3. Performance (PQ) - a client-focused verification of test method output to confirm manufacturer's intent for the system to carry out its functions, and remain within customer's test requirements.
4. Software Validation - computerize transcription and communication is up to part and insync with functions and commands according to manufacturer/supplier's intent based on the client's, industry's, and federal standards.
Preventive Maintenance
If you are a GMP/GLP facility, based on the following regulations, USP 1058, 14 CFR 43, ISO 9001 and 17025, it is good practice to routinely have your equipment checked, calibrated, and maintained, to ensure optimization of your instruments' performance and laboratory uptime, in order to minimize QMS violations such as OOS/OOT/recalls in manufacture, and have the ability to identify any technical and equipment failure. Consumables are replaced and tested at the time of PM.
Mapping
The way MPG conducts Mapping:
1. Verification the equipment/room to be serviced
is within calibration and/or room specification
2. Check on the validation equipment accuracy requirements
3. Comply with 21 CFR 11 Requirements
4. Execute qualifications (IQ/OQ/PQ/), thermal validation testing, distribution testing, and penetration testing
Consulting - Training/Method Development/SOP
MPG also provide the following consulting services:
1. Training - Equipping your team to efficiently make use of the laboratory equipment, and/or suitably organize the lab to maximize workflow and efficacy
2. Method Development - whether a new project is at hand, or problematic situation with an existing project, MPG can step in and assist in assigning the appropriate instrumental and chemical parameters, as well as the proper investigative/QC tests required for raw material, production checkpoints, final product, and release material.
3. SOP - Review, editing, writing, implementation & initiation
Audit Resolution Plan
MPG is able to help you recover from an audit, in implementing and initiating a plan that may cover every aspect of the audit report and correct any findings that may violate internal policies or QMS, and/or violate any other regulations or requirements pertaining to a client, federal agency, or the industry in general.
- Step 1. Cover our basis by completing a bilateral NDA
- Step 2. Reviewing the audit report and providing a plan and proposal
- Step 3. Upon approval of the plan and proposal, officially implement and initiate the plan throughout the facility (plant and/or laboratory)
- Step 4. Follow up and track the progress and success of the plan
- Step 5. Provide a report draft for the client to show improvement based on the duration of the resolution plan
- Step 6. If a re-audit is required after resolution and implementation support will be available during the re-audit.