GMP · Good Manufacturing Practice

GMP – Good Manufacturing Practice Consultancy

Establish the premises, equipment, personnel, process and documentation controls that ensure products are consistently produced and controlled to quality standards.

About GMP

Good Manufacturing Practice (GMP) is a system of practices and controls that ensures products are consistently produced and controlled according to quality standards appropriate to their intended use. GMP requirements are set out in regulations, guidelines and customer codes that vary by sector, including food, pharmaceuticals, cosmetics, nutraceuticals and medical devices.

Innovative Quality Consultancy helps manufacturers understand the GMP requirements applicable to their products and build the facility controls, procedures, records and training that demonstrate compliance to customers, auditors and regulators.

Core elements of GMP

  • Premises and facility design: layout, flow of materials and people, zoning, ventilation, lighting and prevention of cross-contamination.
  • Equipment: suitability, cleaning, maintenance, calibration and qualification where required.
  • Personnel: hygiene, health, training, protective clothing and defined responsibilities.
  • Materials: supplier approval, receipt, storage, identification, status labelling and traceability.
  • Production and process controls: validated processes, in-process checks, line clearance and control of deviations.
  • Cleaning, sanitation and pest control programmes.
  • Quality control, laboratory controls and product release.
  • Documentation: standard operating procedures, batch manufacturing and packaging records, specifications and change control.
  • Complaints, product recall, deviations, corrective and preventive actions and self-inspection.

Suitable organizations

  • Food, spice, snack and beverage manufacturers and packers.
  • Pharmaceutical, ayurvedic, nutraceutical and cosmetic manufacturers.
  • Medical device and packaging material manufacturers, and contract manufacturers serving regulated customers.

Business benefits

  • Consistent product quality and reduced contamination, mix-up and error risk.
  • Compliance with sector regulations and customer GMP codes.
  • Documented batch records and traceability that support investigations and recalls.
  • Readiness for customer, regulatory and certification audits.
  • A practical foundation for ISO 22000, HACCP or ISO 13485 implementation.

How Innovative Quality Consultancy supports you

Innovative Quality Consultancy supports your organization through every stage of implementation:

  1. GMP gap assessment of your facility, processes and documentation against applicable requirements.
  2. Facility and process improvement recommendations and zoning plans.
  3. GMP documentation: SOPs, batch records, specifications, cleaning and maintenance programmes.
  4. Personnel hygiene and GMP awareness training and internal auditor training.
  5. Internal audits (self-inspection), corrective action support and audit readiness.

GMP certification or regulatory GMP approval, where applicable, is granted by an independent certification body or the relevant regulatory authority. Applicable GMP requirements depend on the product category and the markets served.

Discuss GMP for your organization

Tell us about your products, processes and timeline and we will outline a practical implementation plan.

Enquire about GMP

From Compliance Requirements to Controlled Business Processes

Start a conversation about GMP implementation, training, internal audits or certification readiness.