How To Make a Good

Medicine (CPOB)
VIKA AYU LESTARI SARAGIH
2118141
 Why ?

Medicine is used to save lives, or restore or maintain health. Ensure that consumers receive high-
quality drugs

Purpose?
• Ensure the drug is made and controlled consistently
• Meet the established requirements-In accordance with the purpose of its use.
• Distribution permit requirements and product specifications
 General Principles of CPOB
 Comprehensive control
 Not only graduated from a series of tests, but quality must be built into the product
 The quality of the drug depends on
Initial material
>Manufacturing process
>Quality control
>Structure
>Personnel
>Tools
 CPOB Principle
CPOB aims to ensure the drug is made consistently, meets the established
requirements and is in accordance with the purpose for which it is used.
CPOB covers all aspects of production and quality control
 CPOB Element
1. Quality management
2. Personalia
3. Buildings & facilities
4. Equipment
5. Sanitation & hygiene
6. Production
7. Quality control
8. Self-inspection and quality audit
9. Handling complaints about products, product recalls & return products
10. Documentation
11. Manufacture & analysis based on contract
12. Qualification & validation.
1. Quality management is responsible for the establishment of a Quality Assurance system that is
designed thoroughly and applied correctly and incorporates Good Drug Manufacturing Methods
including Quality Supervision and Quality Risk Management.
2. Personnel The pharmaceutical industry is responsible for providing qualified personnel in sufficient
quantities to carry out all tasks.
3. Buildings and facilities have adequate design, construction and location, as well as adjusted in
conditions and maintained properly to facilitate the implementation of correct operations
4. Tools
Equipment for drug manufacturing must have
• precise design and construction
• adequate size
• placed and qualified appropriately, so that the quality of the drug is guaranteed according to the design and
uniform of the batch-bets
• can facilitate cleaning and maintenance in order to prevent cross-contamination
• stacking of dust or dirt and, which generally has a bad impact on product quality
5. Sanitation and hygiene
 Personnel
 Building
 Equipment
 Equipment
 production material
 Container
 cleaning or disinfection material
7. Quality Supervision
Quality Supervision includes :
 sample taking
 Specific
 testing and including settings
 Documentation
 graduation procedures that ensure that all relevant tests have been carried out
 and materials are not approved for use
 products are approved for sale
 the mute has been proven to meet the requirements.
8. Self-inspection, quality audit and supplier approval and audit:
Quality audit is useful as a complement to self-inspection. Quality audit includes the examination and assessment of all or as
of a quality management system with specific objectives to improve it
9. HANDLING PRODUCT COMPLAINTS AND PRODUCT RECALL
 All complaints and other information related to the possibility of drug damage must be carefully reviewed in accordance
with written procedures.
10. Documentation
Clear documentation is fundamental to ensure that each personnel receives a clear and detailed relevant job description
so as to minimize the risk of misinterpretations and errors that usually arise because they only rely on oral
communication.
11. MANUFACTURE AND ANALYSIS BASED ON CONTRACT
A written contract between the Contractor and the Contract Recipient must be made clearly which determines the
responsibilities and obligations of each party
12. QUALIFICATION AND VALIDATION-VALIDATION PLANNING
 All validation activities must be planned.
 The main elements of the validation program should be clearly detailed and documented in the Validation Master
Plan (RIV) or equivalent document.
TERIMA KASIH