Case Studies

Hereunder selected project references highlighting BQG's expertise within its different practices:

Teamwork & Quality Expertise for Timely Corrections & Improved Compliance in Manufacturing

With the expertise of The Biotech Quality Group (BQG), a major Biopharmaceutical company reduced a large backlog of deviations to less than 5% by the FDA-mandated deadline in one of its filling facilities and decreased occurrence of additional deviations, incorporating compliant and efficient manufacturing procedures.

Discover how by reading the full Success Story here

Fast-Track Consulton Qualification & Validation for Increased Capacity

With the expertise of the Biotech Quality Group (BQG),a major pharmaceutical company successfully started up a new production line, while dramatically shortening the required shutdown period and achieving high compliance in the quality and documentation requirements, following the verification approach according to the ASTM E2500.

Discover how, download the pdf here.

 

Context:

In December 2011, our biopharma customer had just completed the construction of a purposed-built mammalian cell lines bio-plant.

BQG was contracted to manage and coordinate the start-up of the plant and test the various installations & systems (upstream / downstream process development) under Verification guidelines - ASTME E2500.

BQG was also in charge of managing the appointed teams to be brought up to speed with the best practices and quality standards by the end of 2013.

Time and materials project capped on budget and planning

 

 Objectives:

  • Conduct a risk-based analysis of the systems as well as compliance status, with respect to the work done up to the end of phase 1 (EPCMV).
  • Build a two-year project plan dedicated to switch and prepare systems for routine production and first GMP campaign.

 

Approach:

As part of BQG's preliminary assessment, a need for a taskforce of experts was identified, to successfully address engineering and routine operations constraints.

Within its own professional network, BQG screened, interviewed and selected professionals from various countries, and submitted a shortlist to the client. A total of 6 experts were selected, seconded with another 2 BQG consultants. The taskforce was led by BQG who was responsible for:

  • The audit of the engineering documentation issued during phase 1,
  • The start-up strategy to successfully manage such a strategic project, involving the production of the first GMP batches by the end of 2013,
  • The overall operational project plan, highlighting out of project, agreed objectives, detailed milestones and detailed planning, key deliverables and reporting structure,
  • Developing systems test plans and related verification tests to convert all systems to a fully functional production plant,
  • Reporting on a weekly basis to the customer, proposing recommendations and managing exceptions.

Results:

Both operational and compliance objectives were successfully met.

As a result of this project success, and upon debriefing with the client, several lessons-learnt were identified:

  • Wherever possible, use important data available at the end of phase 1 (EPCMV). Complete them if necessary.
  • Ensure continuity between audit carried out in phase 1 and those planned in phase 2. Connect user needs with the planned tests, review the work done in the context of critical quality attributes (CQA) for the product and the safety of the patient,
  • Provide a rationale to justify the extent of the tests made in phase 2, based on a risk analysis documented. 

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Context: 

 

European biopharmaceutical corporation going through large CAPEX projects.

Internal dedicated engineering team (> 20 field engineers) facing heterogeneity in engineering documentation and practices.

Willingness to enhance knowledge based on engineering good practices.

BQG was entrusted with the responsibility to support the engineering department in order to improve current engineering standards and project management easy-to-use set of tools.

Fixed-price project based on deliverables

 

Objectives:

 
  • Develop a suite of engineering guidelines describing key development phases, which can be immediately used and deploy on project.
  • Define a roadmap to improve engineering best practices over-time.

 

Approach:

 

A project plan was setup with the customer, focusing on selected key systems. BQG scoped out the project, agreed objectives, project plan, milestones and key deliverables. A BQG project lead was appointed.

A 10-step roadmap was developed, split in various engineering modules. These modules could be used as stand-alone or combined with each other, ensuring maximum flexibility for engineering project plans.

All modules enabled fast-track implementation, related lead-time were carefully assessed to generate maximum savings on existing projects.

This modular approach was brought to life leveraging BQG's unique intelligence platform, part of the Apollo solutions (KorteX). Not only were the guidelines updated with latest engineering guidelines, but the documentation and tools were as well integrating most recent quality and compliance standards.

To avoid any potential quality and/or engineering issues, visual instructions were also built as part of the packages, in order to ensure smooth and efficient deployment within the team.

 

Results:

 
  • A total of 15 individual modules were identified and 4 were delivered as a short term plan to improve quality standards in the engineering department.
  • Enhanced engineering culture and knowledge. The customer was immediately in a position to retain control on future revisions for each of the files.
  • Additional modules were requested by the customer, which have been since then successfully developped and implemented.

 

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Context: 

 

International multi-sites biotech corporation, mixing old and fully new facilities under USP/DSP manufacturing processes.

Challenge: old facilities were facing difficulties in accommodating new manufacturing processes, generating QA out of specifications impacting batches release. A backlog of deviations and CAPA needed to be urgently resolved.

The Client was seeking external support through classical consulting assistance (time and materials).

There were also several internal projects underway and the client was keen to ensure that any learning and success factors from the non-conformity and CAPA backlog project was communicated and integrated into these in-house initiatives.

Fixed-price project based on deliverables, milestones and planning.

 

Objective:

 

To stabilize, clean and decrease the current deviation and CAPA backlog in 6 months by resolving 12 deviations and 30 CAPA per week while still respecting local procedures, impact assessment, good investigations practices, and risk managemen

This was performed using a fixed-price approach.

 

Approach:

 

BQG conducted a kick-off meeting with Client to scope out the project, agree objectives, project plan, timing reporting and key deliverables.

A 5-person task force from BQG was assembled. They followed an integration orientation to be trained on the tools they will be using, the client process and procedures based on BQG best practices to ensure they were effective from Day 1 of the project.

The BQG taskforce was on-site at the client site for the duration of the project

 

Results:

 
  • Deviation and CAPA back log decreased to zero two weeks earlier than planned.
  • Client was extremely satisfied with the results and speed at which this was addressed and appreciated the work ethic and professionalism of the BQG task force.
  • BQG were invited to stay and build another team to follow up on other deviation back logs.

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