Application of Pharmacovigilance Quality Management Standards in Capsule Gelatin Production Enterprises

background

On May 13, 2021, on its official website, the National Medical Products Administration issued the " Pharmacological Vigilance Quality Management Specification" through the "Announcement of the National Medical Products Administration on Issuing the " Pharmacovigilance Quality Management Specification" (2021 No.
65)" "
.

The "Pharmacological Vigilance Quality Management Standards" will be implemented on December 1, 2021

1.
Pharmacovigilance activities and gelatin for capsules

Pharmacovigilance activities refer to the activities of monitoring, identifying, evaluating and controlling adverse drug reactions and other adverse drug-related reactions
.

Gelatin for capsules is a product obtained by incomplete acid hydrolysis, alkaline hydrolysis or enzymatic degradation of collagen in animal skin, bone, tendon and ligament, or a mixture of the above three different gelatin products

2.
The purpose and significance of establishing a pharmacovigilance system for capsule gelatin manufacturers

Capsule gelatin manufacturers establish a pharmacovigilance system to monitor, identify, evaluate and control the adverse reactions of capsule gelatin and other harmful reactions related to capsule gelatin through effective operation and maintenance of the system, so as to minimize the safety risk of capsule gelatin.
, Protect and promote public health
.

3.
How to carry out vigilance management for capsule gelatin manufacturers

Management work can be implemented in accordance with planning, implementation, inspection and improvement
.

Of course, capsule gelatin manufacturers must carry out vigilance management, and also implement them in accordance with the plan, implementation, inspection and improvement

       (1) Plan

       Capsule gelatin manufacturers should establish a capsule gelatin alert system and systematically plan corporate alert management
.

First of all, companies should develop vigilance plans and vigilance quality targets

       (2) Implementation

       1.
Organization

       Capsule gelatin manufacturers should establish a safety committee, set up a special security department, clarify the responsibilities of the security department and other relevant departments, establish a good communication and coordination mechanism, and ensure the smooth development of security activities
.

The legal representative or main person in charge of the capsule gelatin manufacturer shall be fully responsible for the alert activities, designate a person in charge of the alert, allocate a sufficient number of appropriately qualified personnel, provide the necessary resources, and organize and coordinate reasonably to ensure the effectiveness of the alert system Achievement of operation and quality objectives

       2.
Personnel

       The security management system personnel of the capsule gelatin manufacturer should include the legal representative who is fully responsible for the security activities; the security leader, appointed by the legal representative, is specifically responsible for security management; the heads of each department are the security management members and are responsible for the security of the department.
Management work; relevant personnel of various departments are responsible for specific alert work according to work requirements
.

       Capsule gelatin manufacturers should carry out pharmacovigilance training, formulate appropriate vigilance training plans based on job requirements and personnel capabilities, carry out training as planned, and evaluate the effects of training
.

The training content shall include basic vigilance knowledge and regulations, job knowledge and skills, etc.

       3.
Equipment

       Capsule gelatin production enterprises shall be equipped with the equipment and resources required to meet the alert activities, and shall manage and maintain the equipment and resources to ensure that they continue to meet the requirements for use
.

       4.
Monitoring and reporting

       Capsule gelatin manufacturers should actively, comprehensively and effectively collect information on adverse reactions during the production and use of capsule gelatin
.

The adverse reaction reports fed back by the adverse reaction monitoring agency shall be analyzed and evaluated, and reported as required

       5.
Risk management

       5.
1 Signal detection

       Capsule gelatin manufacturers should carry out signal detection on the adverse reaction information collected through various channels to discover new safety risks in a timely manner
.

Appropriate, scientific and effective signal detection methods should be selected according to their own conditions and product characteristics

       5.
2, risk assessment

       Capsule gelatin manufacturers should promptly evaluate new safety risks, analyze influencing factors, describe risk characteristics, determine risk types, and evaluate whether risk control measures are required
.

       5.
3, risk control

       According to the results of the risk assessment, the manufacturer of gelatin for capsules shall comprehensively consider the risk characteristics, substitutability, and socio-economic factors for the identified safety risks, and adopt appropriate risk control measures
.
Routine risk control measures include revising instructions, labels, packaging, changing packaging specifications, and changing management status
.
Special risk control measures including through communication and education, the use of part of the restrictions
.
Where emergency control is required, measures such as suspension of production, sales, and product recall can be taken
.

       Capsule gelatin manufacturers shall purchase special risk substances from raw materials, purchase from risk-free countries and regions, and risk-controllable countries and regions, and require suppliers to provide animal product inspection and quarantine certificates; for melamine, they shall pass inspections and inspections.
Provide a statement to control; for plasticizers, packaging materials should be purchased to check, and the purchased packaging materials should be tested and suppliers should be required to provide test reports and statements to control; allergens should be managed from the entire supply chain to ensure that Introduce new allergens, and secondly make labels to inform high-risk groups; pesticide and veterinary drug residues should be checked from the purchase of raw materials, through testing and requiring suppliers to test and provide declarations to ensure that the gelatin used in the production of capsules does not contain pesticides and veterinary drugs; The management of pathogenic bacteria should be strengthened to eliminate and reduce the chance of contamination by pathogenic bacteria
.

       5.
4.
Risk communication

       The production enterprise of gelatin for capsules shall transmit the safety information of gelatin for capsules to customers and the public, and communicate the risks of gelatin for capsules
.
Capsule gelatin manufacturers should formulate vigilant communication management documents, determine different communication purposes, and adopt different risk communication methods and channels
.

       6.
Documents and records

       Capsule gelatin manufacturers should formulate complete warning systems and procedures
.
Documents for vigilance activities should be reviewed by the pharmacovigilance department
.
System and procedure documents shall be drafted, revised, reviewed, approved, distributed, replaced or revoked, copied, kept and destroyed in accordance with the document management operating procedures, and shall have corresponding records of distribution, revocation, duplication and destruction
.
System and procedure documents should be stored in categories, clearly organized, and easy to consult
.
The system and procedure documents shall indicate the name, category, serial number, version number, review and approval personnel, and effective date, etc.
The content description shall be accurate, clear, and easy to understand, with a revision log attached
.
Capsule gelatin manufacturers should conduct regular review of the system and procedure documents to ensure that the current documents are continuously appropriate and effective
.
System and procedure documents shall be updated in a timely manner in accordance with the requirements of relevant laws and regulations
.

       A gelatin manufacturer for capsules should create and maintain a master document of the alert system to describe the gelatin alert system and activities for capsules
.
The content should include: basic information of the organization, the person in charge of pharmacovigilance, full-time staffing, information sources of adverse reactions, information tools or systems, management systems and operating procedures, operation of the pharmacovigilance system, entrustment of pharmacovigilance activities, quality Management and appendices
.

       Capsule gelatin manufacturers shall standardize the process and results of recording pharmacovigilance activities, and properly manage the records and data generated by pharmacovigilance activities
.
Records and data should be true, accurate, and complete to ensure traceability of pharmacovigilance activities
.
The records and data related to key pharmacovigilance activities should be confirmed and reviewed
.
Records should be filled out in time.
If the carrier is paper, it should be clear, easy to read, and not easy to erase; if the carrier is electronic, the entry authority should be set, and it should be backed up regularly, and it should not be changed at will
.
Specific measures should be taken at each stage of the preservation and processing of pharmacovigilance records and data to ensure the safety and confidentiality of records and data
.
Pharmacovigilance records and data shall be kept for at least ten years after the cancellation of the drug registration certificate, and effective measures shall be taken to prevent the records and data from being damaged or lost during the preservation period
.

       Three, check

       Capsule gelatin manufacturers should conduct regular internal audits to evaluate the suitability, adequacy and effectiveness of the pharmacovigilance system
.
First, there should be an audit plan, specifying the frequency of internal audits, etc.
; second, there should be an audit plan, specifying the purpose, scope, and basis of the audit; third, there should be an audit checklist; fourth, there should be an audit report And its follow-up tracking content
.
In addition, the first meeting and the last meeting can also be held.
The most important thing is to keep relevant records as evidence
.

       Fourth, improve

       Capsule gelatin manufacturers should investigate the causes of the problems based on the problems found in the internal audit and the risks of the new monitoring, take corresponding corrective and preventive measures, and track and evaluate the corrective and preventive measures, so as to continuously improve the capsule gelatin Vigilance management system
.

to sum up

       Capsule gelatin manufacturers should establish a vigilance management system in accordance with the method of establishing a quality management system, and implement dynamic management and continuous improvement
.

       About the author: Lao Chen, quality management expert, has been engaged in quality management and quality control related work in the food and pharmaceutical industries for nearly 20 years, and has served as QA supervisor, quality director, quality manager and production plant director
.
A well-known multinational gelatin company in China is responsible for quality and food safety management system management
.