GAMBAT INSTITUTE OF MEDICAL SCIENCES TENDER DOCUMENTS FOR THE PURCHASE OF SUPPLY OF DRUGS /MEDICINE /CONSUMABLES / OTHER STORE STOCK / MISC: ITEMS. FOR (LIVER TRANSPLANT / CARDIOLOGY / KIDNEY TRANSPLANT) CALLED ON 03-06-2016 AT GAMBAT INSTITUE OF MEDICAL SCIENCES GUIDELINES FOR USAGE OF STANDARD SPECIFICATIONS OF DRUGS / MEDICINES Finished Drug Products REGULATORY REQUIREMENTS: All Finished Drug Products (FDPs) or finished goods (ready for use) should have evidence of registration and latest renewal status with the Ministry of Health, Government of Pakistan (GOP) under the Drugs Act, 1976. According to the rules framed by the GOP under Public Procurement Rules-2004, specifications shall allow the widest possible competition and shall not favor any single contractor or supplier nor put others at a disadvantage. Specifications shall be generic and shall not include references to brand names, model numbers, catalogue numbers, or similar classifications. However, if the procuring agency is convinced that the use of or a reference to a brand name or a catalogue number is essential to complete an otherwise incomplete specification, such use or reference shall be qualified with the words “or equivalent”. IDENTIFICATION : Each FDP must be identified by the International Non-proprietary Name (INN) or generic name thus: − The Active Pharmaceutical Ingredient (API) base or the pro-drug compound, salt or ester, as applicable. − The pharmaceutical dosage form − The amount of active ingredient in each unit dosage form; where this is given in terms of the salt, ester or pro-drug, the equivalent amount of active moiety must be specified. − Route of administration. MONOGRAPH SPECIFICATIONS: The Gambat Institute of Medical Sciences may accept any of the following internationally recognized pharmacopoeia monographs for drugs: − The British Pharmacopoeia (BP), − European Pharmacopoeia (Ph. Eur), − International Pharmacopoeia (Ph. Int) − United States Pharmacopoeia (USP). • Whenever used, the year of publishing of the pharmacopoeia must be specified. • If there is no monograph, manufacturers specifications are acceptable.
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GAMBAT INSTITUTE OF MEDICAL SCIENCES
TENDER DOCUMENTS FOR THE PURCHASE OF SUPPLY OF DRUGS /MEDICINE /CONSUMABLES / OTHER STORE STOCK / MISC: ITEMS. FOR (LIVER TRANSPLANT / CARDIOLOGY / KIDNEY TRANSPLANT) CALLED ON 03-06-2016 AT GAMBAT INSTITUE OF MEDICAL SCIENCES
GUIDELINES FOR USAGE OF STANDARD SPECIFICATIONS OF DRUGS / MEDICINES
Finished Drug Products
REGULATORY REQUIREMENTS:
All Finished Drug Products (FDPs) or finished goods (ready for use) should have evidence
of registration and latest renewal status with the Ministry of Health, Government of
Pakistan (GOP) under the Drugs Act, 1976. According to the rules framed by the GOP
under Public Procurement Rules-2004, specifications shall allow the widest possible
competition and shall not favor any single contractor or supplier nor put others at a
disadvantage. Specifications shall be generic and shall not include references to brand names,
model numbers, catalogue numbers, or similar classifications. However, if the procuring
agency is convinced that the use of or a reference to a brand name or a catalogue
number is essential to complete an otherwise incomplete specification, such use or
reference shall be qualified with the words “or equivalent”.
IDENTIFICATION: Each FDP must be identified by the International Non-proprietary Name (INN) or generic
name thus:
− The Active Pharmaceutical Ingredient (API) base or the pro-drug compound, salt or
ester, as applicable.
− The pharmaceutical dosage form
− The amount of active ingredient in each unit dosage form; where this is given in terms
of the salt, ester or pro-drug, the equivalent amount of active moiety must be specified.
− Route of administration.
MONOGRAPH SPECIFICATIONS: The Gambat Institute of Medical Sciences may accept any of the following internationally
recognized pharmacopoeia monographs for drugs:
− The British Pharmacopoeia (BP),
− European Pharmacopoeia (Ph. Eur),
− International Pharmacopoeia (Ph. Int)
− United States Pharmacopoeia (USP).
• Whenever used, the year of publishing of the pharmacopoeia must be specified.
• If there is no monograph, manufacturers specifications are acceptable.
GENERAL REQUIREMENTS FOR DOSAGE FORMS:
Each FDP should comply with the general requirements for dosage forms of the
relevant edition of BP, Ph.Eur, Ph.Int or USP. At the minimum, all dosage forms must be
packed:
− To facilitate course-of-therapy usage, unless specified otherwise.
− Along with calibrated dose measuring and delivery devices as applicable.
− In tamper-evident packaging.
− In rigid paperboard boxes (unit carton and master carton), strong enough to
resist crushing during transportation, handling and storage.
PACKAGIN: The packing material that is in direct contact with the dosage form is called primary
package or immediate container e.g. aluminum/PVC foil (blister) is primary package in
case of tablets dosage form. A secondary package is not directly in contact with the
dosage form e.g. paperboard boxes (unit carton). All packaging must be designed so as
to protect the dosage form and to render it suitable for the intended use throughout the
stated shelf life.
− All the packing Materials used must conform to the relevant edition of the BP,
USP, Ph.Eur or Ph.Int with reference to the specific API and dosage form; must be
safe for use with the dosage form for the intended route of administration; and
be suitable for transportation, handling storage at extreme temperatures and
humidity.
− Packaging must facilitate the distribution to the lowest level health facilities as
well as dispensing to individual patients and their subsequent adherence. Product
packaging that facilitates patient adherence is encouraged.
− The size of the container should be proportional to its contents with the addition of
appropriate padding to prevent damage to the product during shipment.
− Liquid should be packed in unbreakable, leak proof bottles or containers.
− Glass bottles must be packed individually in cartons.
− For glass ampoules, single ended, break-off necks are preferred. Alternatively,
packages should include an adequate supply of ampoule files facilities breaking.
− Light sensitive product should be packed in light resistance containers.
− Individual ampoule should be packed in plastic or carton trays (5 to 10
ampoule) with the trays packed (for example, in amount of 100) in outer carton.
− All the liquid preparations must be pilfer proof or bottles must be sealed.
LABELS Both languages, Urdu and English, should be mentioned on the label.
− Type of labels: Labels should preferably be direct on the container/packaging.
Self-adhesive labels should be used and the paper of the label should be
protected against humidity, be affixed to be tamperproof and prevent
detachment during transportation.
− The writing on primary and secondary packs must be in indelible ink.
INFORMATION REQUIRED ON LABELS:
The label and packing should be in accordance with the Drugs (Labeling and Packing)
Rules, 1986 or any latest instruction issued by Ministry of Health. The following label
information is mandatory for Finished Drug Products to be supplied for Gambat Institute
of Medical Sciences:
− International Non-proprietary Name (INN) or generic name or pharmacopoeial name of the drug and brand name/trade name, in a bold, clearly visible font size. Names must not be abbreviated anywhere, including on labels and package inserts.
− Amount of API or active moiety per dosage unit, unit of volume or unit of weight.
− Pharmaceutical dosage form. The pharmacopoeia standard of the Finished Drug Product;
− Net quantity per unit pack labeled on that unit pack (primary, secondary, tertiary) in a visible manner.
− Directions for use. − Any special instructions for use e.g. “to be swallowed whole - do not chew”. − Storage instructions. − Special storage and handling instructions, including warnings and precautions. − If a product has a limited shelf life after the primary package is opened and
manipulated, this should be indicated on the label − The shelf life of reconstituted drugs must be mentioned on the label. − For products requiring reconstitution before use (for example, powder for
Injection) instructions should be on the label.
− “Keep out of reach of children“statement
− Batch identification.
− Manufacture date.
− Expiry date in a format that can be easily understood. The items should be a long expiry.
− Name and address of manufacturer. In case product is marketed under mutual manufacturing contract, indicate as: manufactured by company A for company B.
INFORMATION REQUIRED ON MASTER CARTON:
Label of the primary packaging must be pasted on the master carton along with the
following additional information.
− Total number of packs placed in the master carton. − The symbols of breakable, keep away from the rain and arrow. − The storages and handling instructions. − Weight and size.
Summary of product characteristics (SPC) and package inserts (patient information leaflets): The SPC as well as a detailed pack insert/patient information leaflet (PIL) as per
standards and norms for each Finished Drug Product must be provided.
SUITABILITY OF BRAND NAMES OR REGISTERED TRADE NAMES:
The INN or generic name or pharmacopoeial name and brand name will be written in equal prominence on all labels and pack inserts. The brand name/registered trade name will not be so prominent as to mask the appearance and readability of the INN or generic name or pharmacopoeial name. SHELF LIFE AND STORAGE:
− The assigned shelf life and recommended storage conditions should reflect the outcome of stability studies and be printed on labels and PIL.
− The manufacturer/supplier is responsible to inform the Gambat Institute of Medical sciences special transport and packaging is required for any drug/medicine, such as cold storage.
− The supplier/manufacturer specify the required minimum shelf life remaining for all pharmaceutical products because of the length of time required for local distribution, it is advisable to include a general condition that, at the time of delivery/arrival, at least 75% of the shelf life should upon receiving.
− The drugs/medicines should be stored in accordance with the storage conditions as recommended by manufacturer.
MANUFACTURING STANDARDS • Good Manufacturing Practice (GMP): FDPs must be manufactured as per GMP guidelines notified by the Ministry of Health.
• Commitment: The manufacturer/supplier shall inform the Programme immediately about any serious quality and/or safety concerns related to the manufacture, control or use of their product, including suspension or cancellation of registration or cancellation/suspension of Drug Manufacturing License.
• The manufacturer/supplier assures to work with the Programme to minimize potential public health risks by actively organizing product recalls of defective products and either in replacing the defective product or covering the direct and related costs related to replacing the defective product within defined timelines as specified in the contractual requirements.
Model secondary packing details of various dosage forms Syrup (120 Milliliters)
Secondary packing items: • Unit carton • Leaflet • Final carton • Master carton
Composition:- • Each unit carton contains a leaflet and 1 strip of 14 tablets • Each final carton contains 50 unit cartons with 700 tablets • Each master carton contains 6 final cartons with 4,200 tablets
Cream (35 Grams):
Secondary packing items:
• Unit carton • Leaflet • Final carton • Master carton
Composition:
• Each unit carton contains a leaflet and 1 alu-tube having 35 gram cream • Each final carton contains 10 unit cartons with • Each master carton contains 100 final cartons with
Capsule (30 Capsules):
Secondary packing items:
• Unit carton • Leaflet • Final carton • Master carton
Composition:-
• Each unit carton contains a leaflet and 3 strips of 10 capsules each. • Each final carton contains 50 unit cartons having with 1,500 capsules. • Each Master carton contains 8 final cartons with 12,000 capsules.
Suspension
Secondary packing items:
• Unit carton • Label • Leaflet • Master shipper
Composition:-
• Each unit carton contains a leaflet and a 60ml glass bottle with label having
30ml dry powder + a 20 ml ampoule of aqua water • Each master carton contains 50 unit cartons
Injection (Ampoule):-
Secondary packing items: • Unit carton • Label • Leaflet • PVC tray • Final carton • Master carton
Composition: • Each unit carton contains a leaflet with 2-cc glass ampoule with label,
348 Draina S Mini 75 ml steriler Ausstreifbeutel 200PCS
349 Mini-spike PZN 200PCS
350 Microskopueberzug steril 25PCS
351 Disposable scalpels ( handle and blade nr. 11 ) 50PCS
352 Disposable scalpels ( handle with blade nr. 21/22 ) 50PCS
353 Disposable scalpels ( handle and blade nr. 11 ) 50PCS
354 Disposable scalpels ( handle with blade nr. 21/22 ) 50PCS
355 Disposable lighthandle covers 2 different sizes ( for lighthandle with camera and for lighthandle without camera )
5
356 Lighthandle cover small without camera disposable 100
pieces
357 Lighthandle cover for handles with camera disposable or reusable
100 10
358 Polyester Halteband REF MFN503400 5
359 Free Flex 1000 ml Ringersolution Infusionsolution 500bags
360 Transfer Device ( Ueberlaufkanuele ) 10
361 PZN 03466213 10
362 Also for ICU and Anaesthesia 10
363 Gore Tex Patches different sizes 10
364 Schaftverlaengerung 50
pieces
365 Knife electrode straight 50
pieces
366 Knife electrode bent 50
pieces
367 Slim line electrosurgical pencil with 2 buttons 50
pieces
368 Bipolar cable 50
pieces
369 APC Handpiece + cable 50
pieces
370 Adapter 50
pieces
371 Adapter 50
pieces
372 Bipolar fcps 50
pieces
373 Bipolar fcps 50
pieces
374 Nessy electrodes ( Omega ) 50
pieces
375 Cable for nessy electrodes 50
pieces
376 Applicator straight bicision waterjet 50
pieces
377 Cartiges for the waterjet 50
pieces
378 Schalenstaender CE/93/42/EWG 50
379 Model No. 242.1310.0 2 x complete 50
380 Befestigungsring No. 200.5610.0 2 x 50
381 Schale 5l no. 200.5600.0 2 x 50
382 Auftritte Model no. 251.1010.0 2 x 50
383 Model no. 251.1030.0 2 x 50
384 70 ml PP container yellow screw cap 55 mm x 44mm
50
385 Normally it is laboratory stuff 50
386 Bifurcation Prothesis 20 x 10 Length 50 cm 10pcs
387 Plastikanhaenger fuer Siebe 30
388 rot 30
389 blau 30
390 gruen 30
391 gelb 30
392 Container Plomben 30
393 Containerschilder nicht selbstklebend 30
394 Diathermie Reiniger 30
395 Indikatorstreifen 30
396 Markierungsstifte schwarz 30
397 Musterreinigungsbuersten 30
398 Barcoderollen 30
399 Etiketten ( neu zu der Liste ) 30
400 Klarsichtbeutel und Schlaeuche von der Rolle in verschiedenen Groessen zum Einschweissen von Sterilgut mit Indikator
30
401 Abdominal Set ( wie in Essen ) 20
402 Extra Kittel reinforced steril XL and L 20
403 Extra Drapes mit Klebestreifen 100 x 150 20
404 Lochtuecher steril 20
405 Tapes 10 x 75 20
406 Suction bags 20
407 Wir haben nur noch 8 Abdeckungsset reichen fuer 20
408 Warwick Schalen ( reusable Polypropylen ) 20
409 Nierenschale 25cm 20
410 Nierenschale 30 cm 20
411 Vielzweckschale 280 ml 20
412 Vielzweckschale 10 cm Duechmesser 20
413 Flow Knit Bioseal Bifurcatiionsprothese 20
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Desinfektionsmatten, fuer Desinfektionsloesungen im Eingang und zum Durchgang zur ICU waeren sehr sinnvoll. 2,00 m x 1,50 m meine ich, aber ich glaube sie haben feste masse.
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415 Patient draping ( urgently ) 200pcs
416 If it is not Halyard only 25 pieces 200pcs
417 Spare gowns ( urgently ) find in the list by halyard 200pcs
418 Spare drapes ( urgently ) 200pcs
419 Bowie Dick Test for the CSSD 200pcs
420 Indicator strips for CSSD 200pcs
421 Nail Brushes Dr. Sajjad was told at the 12.05 200pcs
422 Key for the Oxygen Zylinder Dr. Sajjad was told 200pcs
423 White scarfs waiting for 6 weeks 200pcs
424 Advan skinstaplers 200pcs
425 10x10 sterile gauze 200pcs
426 Sponges 200pcs
427 Lap sponges 45x45all with x ray sign and sterile 500each
428 Surgical blades No. 11,15,21/22 200
429 Suction connecting tube 0123 ultra fine 200
430 Suction tip Pennine cy 3600 200
431 lockers for the changing room, male and female with small lockers
2
432 Locker for CSSD with small lockers 5
433 Small bedsheets for patient beds 20
434 Small blankets 20
435 steel bins in OTs 4
436 packing table for the CSSD 100 x 70 1
437 sink and working table in cleaners room 1
438 sink with a big hole ( for blood and patients fluid in the room behind the cleaners room
1
439 Ventilator circuit Adult 10box
440 Ventilator circuit paed 5box
441 Suction connecting tube size ¼’’ ( 6 mm ) 2.5 m long
200PCS
442 Warming blankets full body Smiths Medical Level 1 50pcs
443 Tourniquet 20
444 I V Stands steel 5 wheels 2 to lock 40
445 Oxygen Zylinder for the crash cart size C 5
446 Paper rolls ( towl dispenser ) 100
447 Laryngoscope handle 10
448 Laryngoscope Blades different sizes disposable 10each
449 Tracheostomy canulas different size 6each
450 Guedel Airways different sizes diposable 6each