GMP Consultancy
PCS engages when GMP compliance has stopped being a culture and started being a checklist. We embed quality into how manufacturers, CMOs and API producers actually run shifts — so the next inspection result is the consequence of how you operate, not the result of a clean-up project.
When this is the right fit
PCS engages with manufacturing and QA leadership when:
A competent authority inspection has closed with one or more critical findings or a major finding on quality system management
More than five CAPAs have exceeded their 30-day closure target and the same deviation themes are repeating across batches
Your annual product review has revealed systemic deviations that local fixes have not resolved
A new MIA, Annex 1 implementation or significant site change is forcing a rebuild of processes that were sized for a smaller operation
Your QP or Head of Quality has flagged that batch release decisions are increasingly relying on judgement calls instead of a working quality system
When this is not the right fit
When you should look elsewhere
- You need a tactical SOP rewrite without addressing the root cause that made the SOP fail in practice
- You want a clean inspection report without changing the operational habits that produced the findings
- You are seeking the lowest day-rate option — our GMP work is led by senior partners, not staff augmentation
- You expect a consultant to write your CAPA responses while your own line management stays at arm's length
What you get
We focus on outcomes that directly strengthen your manufacturing compliance posture.
GMP Quality System Design
Complete pharmaceutical quality system architecture: quality manual, SOP framework, batch record design, change control, deviation management, and annual product quality reviews. Built for your specific operations, not copied from templates.
Inspection Readiness & Remediation
Systematic preparation for competent authority inspections. If findings already exist, we develop and execute remediation plans that address root causes — not just symptoms.
Process & Cleaning Validation
Validation master plans, process validation protocols, cleaning validation strategies, and equipment qualification. Practical documents your production team can actually execute.
Interim Quality Leadership
Experienced professionals who can step into QA Director, QP, or Head of Quality roles on short notice. They maintain compliance momentum during transitions while transferring knowledge to your permanent team.
EU GMP Annex Compliance
Gap assessments and implementation support for specific Annex requirements — including Annex 1 (sterile manufacturing), Annex 11 (computerised systems), Annex 15 (qualification and validation), and Annex 21 (importation).
How we work
Every GMP engagement starts with understanding your specific regulatory and operational context. Common engagement models:
1–3 weeks
Clear baseline, clear priorities
Typical deliverables
- On-site GMP gap assessment against EU GMP Parts I/II and relevant Annexes
- Risk-classified findings with regulatory impact assessment
- Prioritised remediation roadmap with resource estimates
3–6 months
Resolve findings, rebuild confidence
Typical deliverables
- End-to-end remediation of inspection findings or audit observations
- SOP and batch record revision with staff retraining
- Validation and qualification activities where required
Ongoing
Continuous expert access
Typical deliverables
- Dedicated GMP consultant available on an agreed schedule
- Regulatory change impact assessments as new guidelines emerge
- Support for annual product quality reviews and self-inspections
Typical timeline
Assessment & Scoping
We review your current quality system documentation, tour your manufacturing facility, and interview key personnel. Within one to three weeks, you have a comprehensive understanding of your GMP compliance position and a realistic plan to address gaps.
Implementation
Our consultants work embedded in your team. We write and revise documentation together, redesign processes where needed, support validation activities, and coach your quality and production staff. Senior consultants lead the work throughout — we do not rotate in junior replacements.
Sustainment & Transfer
Compliance must outlast the consultancy engagement. We verify that all changes are documented, personnel are trained, and your internal audit programme covers the improved areas. You retain full ownership of all deliverables.
What clients see
Example (anonymised)
A mid-size pharmaceutical manufacturer received multiple major findings during an EU GMP inspection, including systemic CAPA and deviation management deficiencies. PCS deployed a remediation team that redesigned the quality system, retrained 40+ production and QA staff, and rebuilt the deviation review process so first-line supervisors owned root cause analysis. The follow-up inspection closed all findings without new critical observations.
See more clients and outcomes →"They understood the regulatory expectations and translated them into something our production team could work with every day. That is rare."
Frequently asked questions
We work with finished dosage form manufacturers, API producers, contract manufacturing organisations (CMOs), packaging and labelling sites, and importation/QP release sites. Our consultants have experience across solid dose, liquids, sterile products, and biological manufacturing.
Yes. We have experienced QPs available for interim assignments who can take on batch certification responsibility while you recruit or during transitional periods. Interim QPs are fully briefed on your product portfolio and quality system before they begin.
We perform Annex 1 gap assessments against the August 2023 revision, covering contamination control strategy, environmental monitoring, barrier technology requirements, and process simulation updates. We then support implementation of the specific changes your facility needs.
We offer rapid-deployment inspection readiness support. This includes mock inspections, back-room preparation, document review, and on-site coaching during the inspection itself. We have supported organisations with as little as one week of lead time.
Yes. While our core expertise is EU GMP (EudraLex Volume 4), many of our consultants also have experience with FDA cGMP (21 CFR Parts 210/211), PIC/S GMP, and WHO GMP guidelines. We frequently support organisations that must comply with multiple regulatory frameworks simultaneously.