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WCA Audit

Introduction to WHO –GMP -Good Manufacturing Practice–Herbal Medicines

 

With the constant increase in the use of herbal medicines worldwide and the rapid expansion of the global market, the safety and quality of herbal materials and finished herbal products have become a major concern for health authorities, pharmaceutical industries and the public.

 

What is Herbal GMP- Good Manufacturing Practice

 

Good manufacturing practices (GMP) is one of the most important tools for this measure. The core requirements for GMP for herbal medicines are common to GMP for pharmaceutical products. 

 

Why Herbal GMP- Good Manufacturing Practice

 

The safety and efficacy of herbal medicines largely depend on their quality.

Requirements and methods for quality control of finished herbal products, particularly for combining/mixing

herbal products, are far more complex than for chemical drugs.

The quality of finished herbal products is also influenced by the quality of the raw materials used.

 

What benefits Herbal GMP brings to business:

 

  • Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers.
  • Increases senior management confidence in the preparedness of manufacturing facilities for inspection

 

Whom Herbal GMP is applicable:

 

Manufacture of herbal medicinal products, raw materials and ingredients manufacturers.

 

Our Consulting approach:

  • Gap Analysis:  Assessment of existing management system practices against the selected standard requirements.
  • Project Plan: Prepare a implementation project plan based on the time lines looking for; 
  • Orientation Training:  Top/Senior Management orientation on selected standard requirements and implementation action plans preparation;
  • Developing different levels of documentation ( Tier 1-3/4): Identification of processes required for the products produced and services provided; External and internal issues affecting the business, interested parties needs and expectations, Framing draft quality policy, organizational objectives, role, responsibility and authority, various risks affecting and opportunities arises, functional and system procedures, different implementation formats and checklists;       
  • System Implementation: Implementation of the selected management system as per the developed documentation;
  • Company-wide Training: Training on detailed clause wise requirements and relating them to their  departments, 5-S implementation, and Internal audit.
  • Internal Audits: Periodic assessment of system implementation and corrective actions.
  • Pre assessment:  Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification
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