GMP certification confirms that a company’s manufacturing processes comply with international Good Manufacturing Practice standards. For many industries, GMP is a mandatory requirement for operating locally and internationally.

Key GMP Requirements 

GMP requirements cover all aspects of manufacturing:

• quality management system
• staff qualification and training
• premises and equipment conditions
• raw material control
• process validation
• documentation and records
• deviation control and corrective actions

The core GMP principle is full control and traceability at every stage.

Documentation Requirements 

Documentation is a critical part of GMP:

• standard operating procedures (SOPs)
• manufacturing instructions
• control and monitoring logs
• validation and calibration reports
• staff training records

All documents must be current, approved, and available for inspection.

GMP Certification Stages 

The GMP certification process typically includes:

• preliminary audit and GAP analysis
• development and implementation of GMP requirements
• staff training
• quality system implementation
• internal audit
• external certification audit
• issuance of the GMP certificate

Each stage requires careful planning and coordination.

GMP Certification Timelines 

Timelines depend on company readiness and production scale:

• initial preparation - from 1 to 3 months
• implementation phase - from 2 to 6 months
• audit and certification - from 2 to 6 weeks

On average, the full process takes between 3 and 9 months.
Common Preparation Mistakes
Companies often face:

• formal or incomplete documentation
• insufficient staff training
• non-compliant facilities
• lack of process validation
• poor audit readiness

Professional support helps minimize risks and delays.

Conclusion 

GMP certification is a comprehensive project that requires a structured approach, resources, and expertise. A properly implemented GMP system improves both compliance and operational efficiency.
If you need GMP certification or audit preparation, contact WorldWideBridge - we will deliver a professional turnkey solution and ensure full compliance with international standards.