BQCIS

Ensuring Manufacturing Quality, Safety & Compliance

Good Manufacturing Practice (GMP) verification by BQCIS assures that your production processes, control systems, and documentation meet sector-specific regulatory benchmarks. Whether in pharmaceuticals, food, cosmetics, or medical devices, GMP underpins product safety and market authorization.

We audit manufacturing facilities against recognized frameworks — including WHO GMP, PIC/S, EU GMP, and FDA cGMP — covering premises, process controls, cleaning validations, traceability, and change management. Our independent assessment ensures your systems maintain consistency, minimize contamination risk, and align with regulatory oversight.

Through GMP verification, clients can reduce product recalls, strengthen regulatory relationships, and gain confidence from stakeholders and consumers regarding production integrity.

Key Activities in GMP Verification

Facility & Cleanroom Audit

Assessment of facility layout, HVAC, air filtration, and cleanroom control against GMP design criteria.

Process Validation & Control

Review of production process controls, sterilization, and validation of critical process parameters.

Material & Component Traceability

Verification of raw materials, batch records, and traceability from input to finished goods.

Cleaning & Sanitation Validation

Auditing cleaning procedures, validation protocols, and residue control systems.

Quality Control (QC) Lab Audit

Verification of QC labs, testing methods, calibration, and compliance with GLP or equivalent standards.

Change Control & Deviation Management

Review of change management systems, CAPA implementation, and documentation consistency.

Personnel Training & Hygiene

Check of staff training records, gowning protocols, and hygiene controls in production zones.

Stability & Shelf-life Review

Evaluation of stability study designs and shelf life determinations for product compliance.

Data Integrity & IT Validation

Auditing electronic record-keeping and IT systems for compliance with 21 CFR Part 11 and data integrity principles.

Key Benefits of GMP Verification

Regulatory Approval

Regulatory Approval Confidence

Facilitates smoother audits and regulatory inspections across markets.

Product Safety

Enhanced Product Safety

Minimizes contamination and variability by verifying control systems.

Customer Trust

Strengthened Customer Trust

Demonstrates your commitment to consistent, safe manufacturing standards.

Operational Efficiency

Operational Efficiency Gains

Identifies process improvements and cost-saving opportunities via audit findings.

Success Story

GMP Verification for Nutraceutical Manufacturer

The Challenge:

A nutraceutical producer needed to verify GMP compliance for international market access, with concerns over batch traceability and contamination control.

Our Solution:

BQCIS conducted a full GMP audit, including facility inspection, process validation, lab controls, training protocols, and corrective action review aligned with WHO GMP and PIC/S standards.

The Result:

The manufacturer achieved GMP verification in 10 weeks, enabling entry into EU and Asian markets and reducing batch rejection rate by 35%.

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