법령 및 고시
처분안 : GMP 검사관 지침과 의약품제조관리기준(GMP) 결함 분류 승인
| 작성자 | 관리자 | ||
|---|---|---|---|
| 작성일 | 2016-01-22 | 조회수 | 808 |
| 국가정보 | 남 아메리카>아르헨티나 | ||
| 출처 | |||
| 원문 | |||
| 첨부파일 | |||
Disposition GMP 조사관을 위한 가이드 및 GMP 결함분류에 대한 ANMAT 승인.pdf(420.3KB)
Abstract
By this Disposition ANMAT approves the guidelines for inspectors of Good Manufacturing Practices.
The Guide includes 12 chapters, which are summarized below:
Chapter 1: Administration and general information
It includes aspects related to the company’s name, registrations (Municipal/Provincial/Health Authority, Technical Director), plans, type of products being manufactured, production activities carried out for third parties, etc.
Chapter 2: Human resources
The most important aspects are those related to staff performance, standardized operating procedures, training programs, organization chart, independence between the responsibilities of the production staff and those of the quality control staff, management of medical control, activities banned inside the plant (smoking, eating, drinking, chewing gum), staff hygiene rules, etc.
Chapter 3: Facilities
Description of facilities and auxiliary areas, etc.
Chapter 4: Water systems
Classifications (drinking water, purified water, water for injectables), etc.
Chapter 5: Storage areas
The following aspects are analyzed: condition of premises, temperature control and recording requirements, need for a cold store area, scales, uniforms, separate areas, classification of areas (receipt, sampling, etc.). Process used for destruction of materials, physically separated areas with restricted access to psychotropic or narcotic drugs, approved operating procedures to be implemented in case of spills of toxic or corrosive products. Need for inspection and authorization by a corresponding organization, according to type of warehouse, etc.
Chapter 6: Product returns
The following aspects are analyzed: identification of returns, standardized operating procedures to deal with returns, recording of actions, separation from psychotropic and narcotic drugs.
Chapter 7: Market withdrawal
Operations are informed to the Departments of Quality/Assurance/Regulatory Aspects. They must also be informed to the ANMAT.
Records of withdrawals and their treatment are taken, etc.
Chapter 8: Production documentation
-Master formula
-Batch process record
-Packaging
-Batch packaging record
Chapter 9: Weighing control
It includes description, procedures, measures to avoid cross contamination during weighing and measuring procedures.
Chapter 10: Production
-Areas
-Equipment
-Operations
-Segregated products
-Sterile products
-Areas for installations/equipment
Chapter 11: Quality control
This chapter analyzes batch numbers and expiration dates, printing of labels/boxes, batch records display, use of automatic machinery, process control at different production stages, type of tests, equipment gauging, standardized operating procedures (raw materials, packaging materials, semi-manufactured product, finished product); whether sampling procedures ensure the quality of the entire batch, list of impurities defined by the national health authority.
Chapter 12: Quality assurance
The responsibility to file the product batch document is established, the compliance of staff with training programs is controlled. Other relevant aspects to inspect include:
- Stability
- Gauging
- Quality audits/ self-inspections
- Process audits
- Claims
It also establishes the classification of deficiencies of Good Manufacturing Practices
By this Disposition ANMAT approves the guidelines for inspectors of Good Manufacturing Practices.
The Guide includes 12 chapters, which are summarized below:
Chapter 1: Administration and general information
It includes aspects related to the company’s name, registrations (Municipal/Provincial/Health Authority, Technical Director), plans, type of products being manufactured, production activities carried out for third parties, etc.
Chapter 2: Human resources
The most important aspects are those related to staff performance, standardized operating procedures, training programs, organization chart, independence between the responsibilities of the production staff and those of the quality control staff, management of medical control, activities banned inside the plant (smoking, eating, drinking, chewing gum), staff hygiene rules, etc.
Chapter 3: Facilities
Description of facilities and auxiliary areas, etc.
Chapter 4: Water systems
Classifications (drinking water, purified water, water for injectables), etc.
Chapter 5: Storage areas
The following aspects are analyzed: condition of premises, temperature control and recording requirements, need for a cold store area, scales, uniforms, separate areas, classification of areas (receipt, sampling, etc.). Process used for destruction of materials, physically separated areas with restricted access to psychotropic or narcotic drugs, approved operating procedures to be implemented in case of spills of toxic or corrosive products. Need for inspection and authorization by a corresponding organization, according to type of warehouse, etc.
Chapter 6: Product returns
The following aspects are analyzed: identification of returns, standardized operating procedures to deal with returns, recording of actions, separation from psychotropic and narcotic drugs.
Chapter 7: Market withdrawal
Operations are informed to the Departments of Quality/Assurance/Regulatory Aspects. They must also be informed to the ANMAT.
Records of withdrawals and their treatment are taken, etc.
Chapter 8: Production documentation
-Master formula
-Batch process record
-Packaging
-Batch packaging record
Chapter 9: Weighing control
It includes description, procedures, measures to avoid cross contamination during weighing and measuring procedures.
Chapter 10: Production
-Areas
-Equipment
-Operations
-Segregated products
-Sterile products
-Areas for installations/equipment
Chapter 11: Quality control
This chapter analyzes batch numbers and expiration dates, printing of labels/boxes, batch records display, use of automatic machinery, process control at different production stages, type of tests, equipment gauging, standardized operating procedures (raw materials, packaging materials, semi-manufactured product, finished product); whether sampling procedures ensure the quality of the entire batch, list of impurities defined by the national health authority.
Chapter 12: Quality assurance
The responsibility to file the product batch document is established, the compliance of staff with training programs is controlled. Other relevant aspects to inspect include:
- Stability
- Gauging
- Quality audits/ self-inspections
- Process audits
- Claims
It also establishes the classification of deficiencies of Good Manufacturing Practices
- 이전글 처분안 : 생물학적 동등성 시험을 필요로하지 않는 의약품의 제형 및 투여경로
- 다음글 처분안 : OTC제품의 Package Insert / Labelling Texts 가이드라인 설정
