Quality, GMP Compliance & Auditing
Quality and GMP compliance activities are essential for ensuring that pharmaceutical products are consistently manufactured, controlled, and documented in accordance with regulatory requirements.
Health authorities expect pharmaceutical companies to maintain effective quality systems, compliant documentation practices, and audit-ready operations aligned with Schedule M, WHO, EU, and US FDA GMP expectations.
A strong quality system helps minimise compliance risks, supports successful inspections and certification.
When Do You Need GMP & Audit Support
and What Are the Key Challenges?
Guidance for pharmaceutical companies preparing for inspections, strengthening quality systems, and maintaining audit readiness under evolving GMP requirements.
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Preparation for regulatory inspections or customer audits
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Review and improvement of existing quality systems
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SOP preparation, revision, or harmonisation activities
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APQR preparation and annual quality review activities
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Internal GMP audits and compliance assessments
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Vendor or supplier qualification audits
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CAPA preparation and remediation support after observations
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GMP documentation review before inspections or submissions
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Inconsistent or outdated SOPs and GMP documents
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Gaps in quality systems identified during audits
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Inadequate documentation practices
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Lack of audit readiness for regulatory inspections
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Delays in CAPA closure and remediation activities
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Maintaining compliance with changing GMP expectations
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Vendor qualification and supplier compliance challenges
Our Approach and What You Will Get
Practical quality system review and compliance improvement support aligned with current GMP expectations and inspection readiness.
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Review of quality systems and existing GMP documentation
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SOP preparation, revision, and harmonisation support
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APQR preparation and documentation review
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Internal GMP audits and facility compliance assessments
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Vendor and supplier audit support
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Mock inspection support based on regulatory expectations
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Identification of compliance gaps and remediation planning
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CAPA preparation and follow-up support
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SOPs and controlled quality documents
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APQR review and preparation support
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GMP documentation review
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Internal audit and compliance observations
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Vendor audit assessment
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Gap assessment against GMP requirements
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CAPA and remediation support
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Inspection readiness support
Why Choose Tacit Medtek and Case Example
Hands-on support for GMP documentation, quality system review, and inspection readiness for pharmaceutical manufacturing facilities.
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Practical understanding of pharmaceutical GMP documentation systems
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Experience supporting inspection readiness activities
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Hands-on support for SOPs, APQR, and quality documentation review
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Structured approach for identifying and addressing compliance gaps
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Flexible support based on site and project requirements
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Focus on practical and sustainable compliance improvements
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Challenge: A pharmaceutical manufacturing facility preparing for an export customer audit identified inconsistencies in SOP formats, incomplete APQR records, and gaps in GMP documentation practices.
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Our Approach: Reviewed existing SOPs and quality system documentation. Performed internal GMP compliance assessment. Supported revision and harmonisation of SOPs. Assisted in APQR review and documentation updates. Conducted mock audit preparation and CAPA planning support.
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Outcome: The facility improved documentation consistency, strengthened inspection readiness, and successfully completed the customer audit with reduced compliance observations.
FAQ
Frequently Asked Questions
Yes. We support preparation, review, and harmonisation of SOPs aligned with GMP requirements.
Yes. Internal audits can be performed to assess compliance readiness and identify improvement areas.
Yes. We support compilation, review, and evaluation of APQR documentation.
Yes. Vendor qualification and supplier audit support can be provided.
Yes. Mock inspections can be conducted based on WHO, EU, or US FDA GMP expectations.
Yes. Support is provided for preparation and follow-up of CAPA and remediation activities.
Yes. Existing quality and manufacturing documentation can be reviewed for compliance gaps.
Support can be provided for WHO, EU, and US FDA GMP-related documentation and compliance activities.
Yes. Gap assessments are performed to identify compliance risks and improvement areas.
Yes. Support can be provided for inspection readiness and compliance preparation for export-focused facilities.
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