GOOD MANUFACTURING PRACTICES FOR PHARMA INDUSTRIES – ECONOMY
News:
Revised manufacturing
rules for drug firms: what changes, and why
What's
in the news?
●
The Indian government recently directed all pharmaceutical companies in
the country to implement the revised Good Manufacturing Practices (GMP) to
bring their processes in line with global standards.
Key
takeaways:
●
The improved standards aim to address
critical issues, including alleged contamination incidents in
India-manufactured products, deficiencies in quality control measures, and
adherence to global guidelines.
●
By ensuring adherence to the revised GMP,
India aims to enhance the quality of
medicines available in both domestic and global markets.
Good
Manufacturing Practices (GMP):
●
GMP is a set of guidelines and quality management principles that ensure
pharmaceutical products, as well as other products in the food and healthcare
industries, are consistently produced and controlled to meet quality standards
appropriate for their intended use.
●
GMP covers
all aspects of the manufacturing process, including the premises,
equipment, personnel, materials, production, quality control, documentation,
and storage of finished products.
Need
for Improved Standards:
1.
Alignment with Global Standards:
●
Implementing the new GMP norms will align
the Indian pharmaceutical industry with global standards, ensuring that the
country's products meet the expectations
of international regulators and consumers.
2.
Contamination Incidents:
●
Numerous incidents of contamination in
India-manufactured syrups, eye-drops, and eye ointments have been reported in
other countries, leading to tragic consequences.
●
These incidents have emphasized the need
for stricter quality control measures.
3.
Identified Deficiencies:
●
A risk-based inspection of manufacturing
units revealed several deficiencies, such as the lack of testing incoming raw
materials, inadequate product quality review, absence of quality failure
investigation, infrastructure issues and the absence of qualified
professionals.
Importance
of Implementing Revised GMP:
1.
Standardized Processes:
●
The improved standards will ensure that
pharmaceutical companies follow standardized processes and quality control
measures, thus enhancing the quality of
medicines manufactured and sold both in India and globally.
2.
Recommendations from Chitan Shivir:
●
The implementation of the revised GMP was
one of the suggested measures during a Chitan Shivir following the
contamination incidents.
●
The stakeholders also recommended the creation of a country-wide IT platform
to promote uniformity in licensing and inspection processes across states.
Benefits
of the Revised GMP Implementation:
1.
Boosting Regulatory Confidence:
●
Uniform
quality standards across the industry will instil
confidence in regulators from other countries, potentially reducing the need
for repeated inspections.
2.
Improving Domestic Market Quality:
●
The implementation of revised GMP will
enhance the quality of medicines supplied within India, benefiting consumers
and public health.
Major
Changes in the Revised GMP Guidelines:
1.
Pharmaceutical Quality System:
●
The new guidelines introduce a
pharmaceutical quality system to ensure consistent product quality and a
thorough investigation of deviations or defects.
2. Quality Risk Management:
●
Companies will be required to conduct risk
assessments and implement preventive
actions to manage quality risks effectively.
3.
Product Quality Review:
●
Regular quality reviews of all products
will be mandated to verify the consistency of quality and processes.
4.
Validation of Equipment:
●
Pharmaceutical companies will have to
validate equipment to ensure the accuracy and reliability of production
processes.
5.
GMP-related Computerized Systems:
●
The guidelines emphasize the use of
computerized systems for GMP-related processes to prevent data tampering and unauthorized access.
6.
Additional Product Requirements:
●
The new schedule lists requirements for
biological products, agents with radioactive ingredients, plant-derived
products, and investigational products for clinical trials.
WAY
FORWARD:
1.
Urgent Implementation:
●
Pharmaceutical companies must immediately
initiate the implementation of the revised Good Manufacturing Practices (GMP)
guidelines.
●
Larger companies have six months, and
smaller companies have a year to comply.
2.
Investment in Upgradation:
●
Prioritize investments in facility
upgradation, modern equipment, and IT systems to meet the new GMP standards.
3.
Employee Training and Awareness:
●
Conduct extensive training programs for
all employees to educate them about the revised GMP guidelines and their
importance.
4.
Quality Control Enhancement:
●
Strengthen quality control processes and
invest in advanced testing equipment and laboratories to ensure product
integrity and safety.
5.
Effective Documentation Systems:
●
Implement robust documentation systems to
maintain comprehensive records of manufacturing processes, quality checks, and
deviations.
6.
Continuous Monitoring and Auditing:
●
Regularly monitor manufacturing processes
and conduct internal audits to assess GMP compliance.
The Indian government's
initiative to implement the revised GMP is a commendable step towards bringing the country's pharmaceutical
industry up to global standards. The successful implementation of these
improved standards will undoubtedly elevate India's status in the global
pharmaceutical arena.