BP-803T(B)/PY-803(B)-CBGS
B.Pharmacy VIII Semester (PCI
Scheme)/
(Non-PCI Scheme)
Examination, June 2020
Choice Based Grading System
(CBGS)
Quality Control and Standardization
of Herbals
Time : Three Hours
Maximum Marks : 75
1. WHO Guidelines on Current Good Manufacturing
Practices (cGMP) for Herbal Medicines
**Overview of WHO cGMP Guidelines:**
- **Introduction to cGMP:** WHO's cGMP guidelines for
herbal medicines aim to ensure that herbal products are
consistently produced and controlled according to quality
standards. These guidelines apply to the entire
,manufacturing process, from the procurement of raw
materials to the final product release.
**Key Components:**
- **Quality Management System (QMS):**
- **Objectives:** The QMS must be designed to ensure
product quality, safety, and efficacy. It involves a
systematic approach to managing the processes that
affect product quality.
- **Elements:** The QMS should include quality planning,
quality control, quality assurance, and quality
improvement.
- **Continuous Improvement:** Regular audits,
inspections, and reviews of processes should be
conducted to identify areas for improvement.
- **Personnel:**
- **Training:** All employees involved in production,
quality control, and other relevant areas should receive
adequate training in cGMP and specific procedures
related to their roles.
- **Hygiene:** Personnel must follow strict hygiene
practices to prevent contamination of herbal products.
- **Premises and Equipment:**
, - **Design:** Facilities should be designed to prevent
cross-contamination and ensure a controlled environment
for the manufacturing of herbal medicines.
- **Maintenance:** Regular maintenance and calibration
of equipment are essential to ensure consistent
performance.
- **Documentation:**
- **Standard Operating Procedures (SOPs):** SOPs
should be established for all critical processes, including
production, quality control, and distribution.
- **Batch Records:** Detailed records of each production
batch must be maintained to ensure traceability and
facilitate investigations in case of product defects.
- **Change Control:** Any changes to processes,
equipment, or materials should be documented and
assessed for their impact on product quality.
- **Production:**
- **Process Validation:** The manufacturing process
must be validated to ensure that it consistently produces
products that meet quality specifications.
- **In-process Controls:** Regular monitoring of the
production process is necessary to detect and correct any
deviations from the established standards.
- **Quality Control (QC):**
B.Pharmacy VIII Semester (PCI
Scheme)/
(Non-PCI Scheme)
Examination, June 2020
Choice Based Grading System
(CBGS)
Quality Control and Standardization
of Herbals
Time : Three Hours
Maximum Marks : 75
1. WHO Guidelines on Current Good Manufacturing
Practices (cGMP) for Herbal Medicines
**Overview of WHO cGMP Guidelines:**
- **Introduction to cGMP:** WHO's cGMP guidelines for
herbal medicines aim to ensure that herbal products are
consistently produced and controlled according to quality
standards. These guidelines apply to the entire
,manufacturing process, from the procurement of raw
materials to the final product release.
**Key Components:**
- **Quality Management System (QMS):**
- **Objectives:** The QMS must be designed to ensure
product quality, safety, and efficacy. It involves a
systematic approach to managing the processes that
affect product quality.
- **Elements:** The QMS should include quality planning,
quality control, quality assurance, and quality
improvement.
- **Continuous Improvement:** Regular audits,
inspections, and reviews of processes should be
conducted to identify areas for improvement.
- **Personnel:**
- **Training:** All employees involved in production,
quality control, and other relevant areas should receive
adequate training in cGMP and specific procedures
related to their roles.
- **Hygiene:** Personnel must follow strict hygiene
practices to prevent contamination of herbal products.
- **Premises and Equipment:**
, - **Design:** Facilities should be designed to prevent
cross-contamination and ensure a controlled environment
for the manufacturing of herbal medicines.
- **Maintenance:** Regular maintenance and calibration
of equipment are essential to ensure consistent
performance.
- **Documentation:**
- **Standard Operating Procedures (SOPs):** SOPs
should be established for all critical processes, including
production, quality control, and distribution.
- **Batch Records:** Detailed records of each production
batch must be maintained to ensure traceability and
facilitate investigations in case of product defects.
- **Change Control:** Any changes to processes,
equipment, or materials should be documented and
assessed for their impact on product quality.
- **Production:**
- **Process Validation:** The manufacturing process
must be validated to ensure that it consistently produces
products that meet quality specifications.
- **In-process Controls:** Regular monitoring of the
production process is necessary to detect and correct any
deviations from the established standards.
- **Quality Control (QC):**
