herbal presentation

1. WHO GUIDELINES ON CGMP
FOR HERBAL DRUGS
PRESENTED BY –
• KAPIL JYOTI NATH (ROLL NO. 28)
• JOY RAJ SEN (ROLL NO. 24)
• MRIGANKA MEDHI (ROLL NO. 38)
• MRINMOY BAISHYA (ROLL NO. 39)
SUBJECT- QUALITY CONTROL AND STANDARDIZATION
OF HERBALS
Presented to- Mr. Shekhar Chandra Bora

2. Current Good Manufacturing Practices (cGMP) are FDA regulations that ensure consistent production and
control of pharmaceutical products, medical devices, food and beverages, and dietary supplements, focusing
on quality, safety, and purity.
• Mandatory Regulations:
cGMPs are mandatory regulations established by the FDA (Food and Drug Administration) to ensure that
products are consistently manufactured to meet quality standards.
• Quality Assurance:
cGMPs are the aspect of quality assurance that ensures that products are consistently produced and
controlled to the quality standards appropriate to their intended use.
• Industry Application:
cGMPs apply to the manufacturing of pharmaceutical products, medical devices, food and beverages, dietary
supplements, and other products regulated by the FDA.
INTRODUCTION

3. • Purpose:
•The main purpose of cGMP is to
prevent harm to the end user by
ensuring the product is free from
contamination, consistent in its
manufacture, and well-documented.

4. → Quality assurance in the manufacture of herbal medicines
→ Sanitation and hygiene
→ Qualification &Validation Complaints
→
→ Product Recalls Contract Production & Analysis
→
→ Self-Inspection Personnel
→
→ Training Personal Hygiene
→
→ Premises Storage areas
→
→ Production Areas Equipment's
→
→ Material Documentations
→
→ Good Practice in Productions
→ Good Practice in Quality Practice
WHO GUIDELINES ON CGMP

5. → Quality assurance in the manufacture of herbal medicines
The use of modern analytical techniques especially HPTLC, GC, HPLC, CE, MS And AA are used to
characterize herbal medicines.
Quality assurance also requires the control of starting materials, storage and processing. For this
reason, an appropriate quality assurance system should be applied in the manufacture of herbal
medicines.
→ Sanitation and hygiene
To avoid alterations and reduce contamination, a high level of sanitation and hygiene is necessary
during the manufacturing process.Water supply to the manufacturing unit
should be monitored and if necessary, treated appropriately to ensure consistency of quality.Waste
bins should be available, emptied, and cleaned at least daily.
WHO GUIDELINES ON CGMP

6. → Qualification &Validation
The written procedure should specify process steps and factors (such as extraction time, temperature
and solvent purity), acceptance criteria and the type of validation to be conducted and the number of
process runs.
→ Complaints
Product quality complaints may be caused by problems such as faulty manufacture, product defects or
deterioration of herbal medicines and adulteration of the herbal material.These complaints should be
recorded in detail and their causes by comparing with the reference samples kept from the same batch.
WHO GUIDELINES ON CGMP

7. → Product Recalls
There should be a standard operating procedure (SOP) for the storage of recalled herbal medicines in a
secure isolated area, complying with the requirements specified.
→ Contract Production & Analysis
Contract should be drawn up by experienced people suitably knowledgeable on the specific
characteristics of herbal medicines including their production and quality control testing.
→ Self-Inspection
One member of the self-inspection should have a through knowledge of herbal medicines.
WHO GUIDELINES ON CGMP

8. → Personnel
All responsible staff should have their duties recorded in written descriptions and adequate authority to
carry out their responsibilities.Their duties may be given to designated deputies of a satisfactory
qualification level.
→ Training
The personnel should have adequate training in appropriate fields such as pharmaceutical technology,
taxonomic botany, phytochemistry, pharmacognosy, hygiene, microbiology and related subjects.
→ Personal Hygiene
Personnel must be protected from contact with toxic irritants and allergenic plant materials using
suitable protective clothing.They should wear suitable gloves, caps, masks, work suits and shoes
throughout the whole procedure from plant processing to product manufacture.
WHO GUIDELINES ON CGMP

9. → Premises
The premises should be designed, located, constructed, adapted and maintained to suit the operations to
be carried out according toWHO guidelines.
→ Storage areas
The areas should be well labelled and materials stored in such a way as to avoid any risk of cross-
contamination.An area should be identified for the quarantine of all incoming herbal materials. Different
herbal materials should be stored in separate areas.
→ Production Areas
To facilitate cleaning and to avoid cross contamination, adequate precautions should be taken during the
sampling, weighing, mixing and processing of medicinal plants.
WHO GUIDELINES ON CGMP

10. → Equipment’s
Effective cleaning of the equipment is therefore necessary.Vacuum or wet-cleaning methods are
preferred. If wet-cleaning is done, the equipment should be dried immediately after cleaning to prevent
the growth of micro-organisms.
→ Material’s
All incoming herbal materials should be quarantined and stored under appropriate conditions. Only
permitted substances should be used for fumigation and allowable limits for their residues together with
specifications for the apparatus used should be set according to the national regulations.
WHO GUIDELINES ON CGMP