About
jan 2023
Welcome to the BMAB family Darek Lindhe
Senior Consultant with 20 years’ experience from R&D in the pharmaceutical industry and development of medicinal products including scale up, tech. transfer and process validation. Several years in a manager role with responsibility for a formulation group, pilot plant, equipment and media as well as internal and outsourced formulation developments
Quality
Q2S, Quality as a Service - Long term Collaboration
We provide following services:
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Hire of QP (Qualified Person)
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Hire of Responsible Person (Distribution of pharmaceuticals)
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Hire of Person Responsible for Regulatory Compliance (PRRC)
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Hire of department QA / QC Managers
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Hire of project QA Managers
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Hire of quality engineers (e.g. complaint investigations, risk evaluations, change and deviation management)
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Analysis and reporting – PQR/APR, Elemental Impurities, Residual Solvents etc.
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Development and maintenance of a Quality Management System (QMS)
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Outsourcing of different QMS areas
Compliance
Audit services
EU/US GMP, GDP, Medical Devices
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Suppliers, Laboratories, internal QA/QC departments, CMO/CRO
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Distributors, re-packers, transport companies of pharmaceuticals
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EU GMP, EU GDP, MDD/MDR, ISO 13485, 21CFR820, 21CFR210/211
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IT Processes, In-house IT departments, Software Development Processes
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Due diligence of QMS processes
QMS related services
GAP analyses, Establishment, reconstruction, extension of QMS systems
- EU GMP, GDP, MDD/MDR, ISO13485, 21CFR820, 21CFR210 or other regulatory requirements
Validation and qualification services
- Manufacturing, laboratories, administrative systems, HVAC etc.
Serialization and aggregation
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Services related to clean rooms / sterile environment
Security
Information Security related services
Records and Information Management
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Routines for Regulatory and Business Critical information
Data Integrity
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Data integrity is a prerequisite for the regulated Life Sciences industry
GDPR
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Establishment of GDPR framework
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GAP analysis / Improvement of GDPR processes
Project Management
Senior Project Managers
IT system introduction / roll out, e.g.
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SAP
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Movex
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EBR systems
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LIMS
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Serialization and aggregation systems
Product Lifecycle Management (PLM)
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Initial conception
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Design control (R&D)
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Industrialization
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Product care
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Product decommissioning
Remote Audits
Why remote audits?
According to current regulations, an audit of the supplier is usually needed as part of the supplier qualification. When the world situation is as it is with travel restrictions, many of these audits cannot be performed. This can be solved with a remote audit (distant assessment), which can be seen as a paper-based audit but with the addition of performing parts of the audit via a web meeting.
Bruun & Maté has developed a "best practice" on how a remote audit can be done. The main steps are:
A risk assessment is performed in collaboration with the customer to evaluate what is important that it is ensured during the audit.
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A detailed audit plan is prepared and sent to the supplier to ensure that they have the right people in place and have the necessary technical equipment.
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The remote audit is conducted based on the risk assessment and the documents obtained from the supplier before the audit.
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An audit report is compiled, and the risk analysis is updated with the results of the audit. An assessment is made of whether a subsequent on-site audit needs to be done when it becomes possible to travel again.
If an on-site audit is considered necessary, it will be done in areas that could not be inspected during the remote audit. This means that this will be a shorter audit focusing on the areas that need further review according to the risk analysis.
We have several senior auditors who can tailor a solution to suit your needs. If you want help with an audit, please contact us.
