Specification
for drugs for opportunistic infections
I. List of drugs should be procured
№ / Name of the pharmaceutical product / Dosage form / quantitytab., caps., amp., bottle., for
2008
1. / Azythromycin / tabs 500 mg / 1 440
2. / Fluconazole / caps 100 mg / 6 600
3. / Trimethoprim/Sulfamethoxazole / tabs 480 mg / 134 820
4. / Cefepime / pwd. for inj. sol., 1,0 g, amp. / 7 560
5. / Moxifloxacin / tabs 400 mg / 2 520
6. / Amikacin / 250 mg/ml, 2 ml vial / 5 040
7. / Amikacin / pwd. for inj. sol., 1,0 g, amp. / 2 520
II. Product Requirements
1. Raw materials
Pharmaceutical products offered under this purchase description shall be produced from validated raw materials obtained from a licensed manufacturer or its authorized distributor. This applies to both active and inactive ingredients.
2. Registration requirements
Pharmaceutical products offered under this purchase description shall be currently registered in Ukraine and approved by the Ministry of Health of Ukraine, period of validity of certificate should be not less than 1 year from the date of Procurement Review Committee meeting.
3. Certificate(s) of licensing
Pharmaceutical products offered under this purchase description shall be licensed for marketing by the drug regulatory authority of the country of origin.. Prior to award of the Contract, the successful offeror(s) may be required to submit a "statement of licensing status of pharmaceutical product(s)" as provided under the World Health Organization (WHO) Certification Scheme.
4. Compliance with good manufacturing practices (GMP)
The Supplier must be able to provide certification that the pharmaceutical products offered under this purchase description are manufactured according to WHO good manufacturing practices (GMP). Such certification can be found in the WHO Certification Scheme "Certificate of a Pharmaceutical Product." Supplier also must be able to provide copies of its annual GMP audit reports.
5. WHO certification
The Supplier must be able to provide documentation indicating the manufacturer of the product has received confirmation from the national regulatory agency of the country of manufacture that the pharmaceutical meets the requirements in the WHO Certification Scheme.
6. Primary container
The primary container should maintain the quality, safety and stability of the product contained. All packaging must be properly sealed and tamper-proof, and packaging components must meet the latest compendium standards and be approved for pharmaceutical packaging by the manufacturer’s national regulatory authority.
7. Labeling
The label of the primary container for each pharmaceutical product shall include:
1. The international nonproprietary name of the active ingredient(s)
2. Dosage form, e.g., tablet, ampoule, etc.
3. Quantity of active ingredient(s) in the dosage form
4. The applicable pharmacopoeia standard
5. Batch/lot number
6. Date of manufacture
7. Expiry date
8. Instruction for storage
9. Name of manufacturer
Labels and medical instruction of usage should be provided in Russian and/or Ukrainian language.
8. Lots per order
The Supplier shall fill the order using the fewest number of manufacturing lots possible.
9. Shelf life
At the time of acceptance for delivery to the country of destination, no more than 25% percent of product shelf life shall have expired since the date of manufacture shown on the batch release or Certificate of Analysis.
The supplier shall be able to provide to the satisfaction of the registration/national quality control authorities the manufacturer's stability test data to validate the product's stated shelf life at ambient temperature 32 degrees C or above and relative humidity of 85%. Variations must be proven scientifically comparable by means of stability data.
10. Workmanship
Products and packaging shall be free of defects that impair their serviceability, affect their durability, or detract from their appearance.
11. Test Data
Chemical and physical test data for raw materials, components, in-process, and finished product testing must be on record for each lot shipped and must be available to Purchaser's representatives when requested.