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Service 27 / 27 · GMP Gap Assessment & CAPA Support

Turn Findings into Evidence, Not Just Answers.

A finding from an inspection or internal audit is rarely closed by a statement that something has been done. What closes it is a proportionate response and evidence that the response works: a revised layout, a qualified system, a monitoring record, an approved procedure. ALVEDA supports the client in assessing technical gaps, classifying them by risk, defining engineering and quality responses and planning the evidence each one needs, then tracks verification through to closeout according to the agreed project scope. ALVEDA is not a regulator and does not decide whether a response is accepted.

Discuss your project

Engineering phases

Where this service fits

04 / 09 phases in scope

  1. 01FeasibilityIn scope
  2. 02Conceptnot in scope
  3. 03Basic EngineeringIn scope
  4. 04Detailed Engineeringnot in scope
  5. 05Procurementnot in scope
  6. 06Constructionnot in scope
  7. 07Commissioningnot in scope
  8. 08ValidationIn scope
  9. 09OperationIn scope

Scope

What the service covers

  1. 01Technical GMP gap assessment of facilities, utilities and systems
  2. 02Review and structuring of findings shared by the client
  3. 03Risk classification and prioritization
  4. 04Engineering and quality response definition
  5. 05Evidence planning and verification approach
  6. 06CAPA tracking through to closeout

Method

From inputs to deliverables

INInputs

05 items
  1. I01Inspection or audit findings shared by the client
  2. I02Existing layouts, system documentation and qualification status
  3. I03Applicable requirements the client has identified for its target markets
  4. I04Existing procedures and records
  5. I05Constraints of the operating facility

WORKActivities

06 items
  1. W01Site walk-down and document review
  2. W02Grouping findings by technical category and root cause
  3. W03Risk classification with the client quality team
  4. W04Response options: engineering, procedural or both
  5. W05Definition of the objective evidence required
  6. W06Verification planning and progress reporting

OUTDeliverables

05 items
  1. D-27.01Gap assessment report
  2. D-27.02Finding and risk classification register
  3. D-27.03CAPA plan with owners and target dates
  4. D-27.04Evidence matrix per finding
  5. D-27.05Verification and closeout tracker

Technical detail

How gaps are handled

    • Facility layout, zoning and flows
    • Cleanrooms, HVAC and pressure cascade
    • Pharmaceutical water and clean utilities
    • Laboratories, storage and waste handling
    • Qualification status and technical documentation

Sequence

From finding to closeout

Each finding follows the same path, so that nothing is closed on a statement alone.

  1. FINDING

    Finding

    The observation is recorded as stated, with its location, system and supporting context.

  2. RISK

    Risk

    Its impact on product, patient and personnel safety is classified to set priority.

  3. RESPONSE

    Engineering / quality response

    The corrective and preventive action is defined: a design change, a system upgrade, a procedure or a combination.

  4. EVIDENCE REQUIRED

    Evidence required

    The objective evidence that will demonstrate the response is agreed before work starts.

  5. VERIFICATION

    Verification

    Implementation is checked on site and in records against the agreed evidence.

  6. CLOSEOUT

    Closeout

    The evidence package is compiled for the client quality unit, which decides on closure.

Interactive engineering model

Explore how the engineering fits together.

From finding to closeout

How a compliance gap is taken through a CAPA-style sequence. Choose an example case and step through each stage.

Illustrative example

Example cases

01 / 06Illustrative example

Pressure relationship not documented between adjacent rooms

Finding

  • The intended pressure direction between two adjacent classified rooms is not stated in the design documents.
  • Operating records show readings, but no defined design intent to compare them with.

Generic cases written for illustration. They do not describe any specific facility, project or inspection.

Deliverables

Typical documents and outputs

  1. D-27.01Gap assessment report
  2. D-27.02Finding and risk classification register
  3. D-27.03CAPA plan with owners and target dates
  4. D-27.04Evidence matrix per finding
  5. D-27.05Verification and closeout tracker

Services

Related services

All services
  • 07

    GMP & Compliance

    Facility design reviewed against GMP requirements at every stage.

  • 08

    Qualification & Validation (CQV)

    Documented evidence that facilities, utilities and equipment perform as intended.

  • 18

    Facility Upgrades & Retrofit

    Expansions, upgrades and retrofits engineered around the facility that is already running.

FAQ

Questions about this service

All questions

  • Yes. Upgrade studies, GMP gap assessments, engineering changes, utility improvements, and expansion planning can be scoped around ongoing production, with phasing, temporary arrangements, and requalification planned to limit disruption.

Next step

Planning a pharmaceutical project?

Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.

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