Purpose of the Guidelines
The official name of the guidelines is "Guidelines for Proper Management of Computerized Systems for Pharmaceutical and Quasi-Drug Manufacturers and Distributors," which was issued by the Ministry of Health, Labor and Welfare (Yakushoku Kannahatsu No. 1021-11) on October 21, 2010 as a replacement for the "Guidelines for Proper Management of Computerized Pharmaceutical Manufacturing Plants" issued in 1992, and came into effect on April 1, 2012. The guidelines show how to manage the entire life cycle of a computerized system, from development to verification, operation management, and disposal. Note that the management methods shown in the guidelines are standard examples, and it is acceptable to use alternative methods that can achieve the same or better objectives.
Scope of application
The guidelines define the purpose as "applicable to manufacturers, distributors, etc. who use computerized systems to carry out operations subject to the GQP Ministerial Ordinance and the GMP Ministerial Ordinance" and provide the following system examples, but they are also considered to be acceptable for application to QMS, GxP, etc. operations at the manufacturer's responsibility, and are therefore widely used as guidelines for computerized system management.
| (1) |
A system for deciding whether or not to shipment pharmaceuticals and quasi-drugs to the market, and a system for creating, storing and managing records related to shipment to the market |
| (2) | A system for creating, storing, and managing manufacturing instructions and manufacturing records |
| (3) | A system for control or managing a manufacturing process and a system for storing and managing the management data |
| (4) | A system for managing the storage, receipt, and disbursement of raw materials and finished products (including those produced in the intermediate manufacturing process; the same applies below) |
| (5) | A system for control or managing equipment used in quality testing, and a system for storing and managing quality test results and management data |
| (6) | Systems for control or managing manufacturing support equipment and facilities that may have a significant impact on product quality, such as air conditioning and manufacturing water production equipment, and systems for storing and managing the management data for these equipment and facilities |
| (7) | A system for creating, approving, storing and managing documents (procedure documents, quality standards, product standards, etc.) |
Overview of the Guidelines
table of contents
| 1. General Provisions |
|
|
| 1.1 |
the purpose |
5.4 |
Operational Qualification (OQ) |
| 1.2 |
Handling computerized systems |
5.5 |
Performance Qualification (PQ) |
| 1.3 |
Category Classification |
5.6 |
Partial omission and quotation of qualification evaluation |
| 2. Scope of application |
5.7 |
Preparation of documentation for the overall validation report |
| 3. Documentation of development, testing and operation of computerized systems |
6. Operational management |
| 4. development work |
6.1 |
Creating documentation regarding operational management procedure |
| 4.1 |
Preparation of development plan documents |
6.2 |
Preparation of documentation for operation procedure for computerized systems |
| 4.2 |
Creating documentation of specifications |
6.3 |
Implementing maintenance and inspection items |
| 4.3 |
Conducting a system assessment |
6.4 |
Security Management |
| 4.4 |
Functional specifications document |
6.5 |
back up and Restore |
| 4.5 |
Creating design specifications documentation |
6.6 |
Change Management |
| 4.6 |
Program creation and program testing |
6.7 |
Management of deviations (system troubles) |
| 4.7 |
System Testing |
6.8 |
Education and Training |
| 4.8 |
Acceptance Testing |
7. Self-examination |
| 5. Verification work |
7.1 |
Conducting self-examination |
| 5.1 |
Preparation of documentation for the overall validation plan |
7.2 |
Implementation of remedial measures |
| 5.2 |
Design Qualification (DQ) |
8. Disposal of computer systems |
| 5.3 |
Installation Qualification (IQ) |
9. Document and record management |
|
|
10. Glossary |
Consistency with GAMP5
GAMP (Good Automated Manufacturing Practice), published by ISPE (International Society of Pharmaceutical Engineers), is a set of guidelines that has become the de facto global standard for computerized system validation.
The Guidelines for Appropriate Management were created with reference to GAMP5, the latest version of GAMP, and are generally said to have almost the same approaches and ideas. The main areas that are similar to GAMP5 include the following:
- Risk-based approach
- Life cycle initiatives (planning to disposal)
- Software categorization initiative (similar to GAMP5 categorization)
- Conducting assessments of suppliers (conducting supplier audits)
- Effective use of supplier activities (quotes from acceptance tests, etc. during validation)
While GAMP5 started out as a guideline for suppliers, the Good Manufacturing Practices Guidelines are compliance requirements for pharmaceutical companies, and as such have different objectives, there are several different approaches.
While GAMP5 uses testing (verification) for the verification of computerized system validation, the Good Management Guidelines use the concepts of DQ, IQ, OQ, and PQ that are also adopted in GAMP4 (the previous version of GAMP5) and the PIC/S guidelines.
Our Response
The Good Laboratory Practice Guidelines have almost the same approach and concepts as GAMP5, and validation is based on the DQ, IQ, OQ, and PQ concepts adopted by many pharmaceutical companies. Therefore, in principle, we carry out computerized system validation based on concepts that comply with the Good Laboratory Practice Guidelines.
We also carry out computerized system validation that complies with validation regulations established by pharmaceutical companies, and respond to supplier audits as necessary.
We not only validate the items implemented by suppliers, but also provide technical support and document creation support for other items after consultation.
