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Quality Objectives
QUALITY OBJECTIVES PHARMACEUTICAL SERVICES PROGRAMME, MOH 2025
Pharmacy Policy & Strategic Planning Division
No | Indicator | Target |
|---|---|---|
1. | Percentage of Pharmacists and Pharmacists Assistant who have achieved the minimum annual CPD requirement set (Pharmaceutical Services Programme MOH) | 100% |
2. | Quotations to be processed within 45 days starting from the closing date of the advertisement to the preparation of SST | 100% |
3. | Average percentage of the availability and accesibility of the Pharmaceutical Services Programme online system | 99% |
Pharmacy Practice & Development Division
No | Indicator | Target |
|---|---|---|
1. | Technical Evaluation of tender medicines in FUKKM to be processed within 18 working days after receiving tender documents and samples | 100% |
2. | Financial Evaluation of tender medicines in FUKKM to be processed within 10 working days after the approval by the Medicines Technical Evaluation Committee | 100% |
3. | Percentage of pharmacy facilities that have achieved a good level of compliance through Pharmacy Practice Internal Audit (Audit Dalam Amalan Farmasi) (ADAF) | 80% |
National Pharmaceutical Regulatory Agency
No | Indicator | Target |
|---|---|---|
1. | Percentage of product registration application screened within 30 working days for all product categories | 95% |
2. | All market surveillance samples shall be analysed within 110 working days from the date of receipt | 100% |
3. | Handling of registered products and notified cosmetics complaints: Complaints received are acted on within 14 days | 100% |
| 4. | Percentage of equipment calibrated and maintained in accordance with the approved annual schedule | 100% |
| 5. | Percentage of Product Recalls issued within the stipulated timeline. Stipulated timeline: not more than one (1) working day from the date a decision is made in Mesyuarat Jawatankuasa Teknikal Kualiti dan Keselamatan Produk & Kosmetik (JTKKPK) | 85% |
| 6. | Percentage of complaint samples shall be analysed within 30 working days from the date of receipt | 100% |
| 7. | The number of complete applications for the evaluation of manufacturing plant layout, completed evaluation within 20 working days. | 90% |
| 8. | The percentage of corrective and preventive action (CAPA) reports for GCP/GLP/BE/EC inspections that are evaluated within 30 working days. Notes: GCP: Good Clinical Practice; GLP: Good Laboratory Practice; BE: Bioequivalence; EC: Ethics Committee | 100% |
| 9. | Percentage of Lot Release certificates for vaccines and plasma-derived products issued within six (6) working days from the date of product arrives at the warehouse | 95% |
| 10. | Percentage of Adverse Drug Reaction (ADR) and Adverse Event Following Immunisation (AEFI) reports achieving vigiGrade Completeness Score exceeding 0.5 | 85% |
| 11. | Percentage of licence (Manufacturer’s Licence, Import Licence, and Wholesaler’s Licence) issued to companies without error | 100% |
| 12. | Average percentage of system Uptime in National Pharmaceutical Regulatory Agency. | 99% |
| 13. | Quotations to be processed starting from the closing date of the advertisement to the preparation of SST (Letter of Acceptance) is issued within:
|
100%
100% |
Effective from January 1st, 2025
Tag:
Quality Objectives Achievement
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