DOC

SECTION VIII TECHNICAL SPECIFICATIONS

By Joe Green,2014-05-19 16:07
9 views 0
Standards of Quality Control for Supply(a) With each consignment, and for each item a WHO certificate of quality control test results concerning

SECTION VII: TECHNICAL SPECIFICATIONS

Technical Specifications

LABORATORY PRODUCTS

1.1 The Goods to be purchased by the Purchaser under this 1. Product and

    Invitation for Tenders are included in the Purchaser’s current Package

    national essential drugs list or national formulary. The Specifications

    required packing standards and label must meet the latest

    requirements of the World Health Organization (WHO) good

    manufacturing practices (GMP) standards in all respects.

    (These standards contained in “Good Practices in the

    Manufacture and Quality Control of Laboratory Reagents.”)

1.2 The Goods should conform to approved standards for

    Laboratory Equipments, Reagents and Supplies. The

    standards will be the latest edition unless otherwise stated by

    the Purchaser or other if applicable. In case the Laboratory

    reagents/goods is not included in (the specified laboratory

    standards, but included in the Purchasers, national health

    laboratory supplies list, the Purchaser should clearly

    indicate acceptable limits and the Supplier, upon award of

    the Contract, must provide the reference, standards and

    testing protocols to allow for quality control testing.

1.3 Not only the products item, but also packaging and labelling

    components (e.g., bottles, closures, and labelling) should also

    meet specifications suitable for distribution, storage, and use

    in a climate similar to that prevailing in the United Republic

    of Tanzania. All packaging must be properly sealed and

    tamper-proof and packaging components must meet the latest

    standards and be approved for laboratory packaging by the

    manufacturer's national Regulatory Authority (RA). The

    Purchaser should specify any additional special

    requirements.

1.4 All labelling and packaging inserts shall be in the language

    requested by the Purchaser or English if not otherwise stated.

1.5 Goods requiring refrigeration or freezing or those that should

    not fall below a certain minimum temperature for stability

    must specifically indicate storage requirements on labels and

    containers and be shipped in special containers to ensure

    stability in transit from point of shipment to port of entry.

1.6 Upon award, the successful Supplier shall, on demand,

    provide a translated version in the language of the tender of

    the prescriber's information for any specific goods the

    Purchaser may request.

    Sec. VI-1

    2.1 The label of the primary container for each reagents shall 2. Labelling

    meet the approved standard and include: Instructions

    (a) the international non-proprietary name (INN) or

    generic name prominently displayed and above the

    brand name, where a brand name has been given.

    Brand names should not be bolder or larger than the

    generic name;

    (b) the active ingredient "per unit, etc.";

    (c) the applicable laboratory standard;

(d) the Purchaser's logo and code number and any

    specific colour coding if required;

(e) content per pack;

(f) instructions for use;

    (g) special storage requirements;

(h) batch number;

(i) date of manufacture and date of expiry (in clear

    language, not code);

    (j) name and address of manufacture; and

    (k) any additional cautionary statement.

    2.2 The outer case or carton should also display the above

    information.

    3.1 All cases should prominently indicate the following: 3. Case

     Identification

    (a) Purchaser's line and code numbers;

    (b) the generic name of the product;

    (c) the dosage form;

    (d) date of manufacture and expiry (in clear language

    not code);

    (e) batch number;

    (f) quantity per case;

    (g) special instructions for storage;

    Sec. VI-2

    (h) name and address of manufacture; and

    (i) any additional cautionary statements.

    3.2 No case should contain laboratory products from more than

    one batch.

    4.1 The Purchaser shall have the right to request the Supplier to 4. Unique Identifiers

    imprint a logo, if the quantity so justifies it, on the labels of the containers used for packaging and this will be in the Technical Specifications. The design and detail will be clearly indicated at the time of tendering, and confirmation of

    the design of such logo shall be provided to the Supplier at

    the time of contract award.

    5.1 The successful Supplier will be required to furnish to the 5. Standards of

    Purchaser: Quality Control

     for Supply

    (a) With each consignment, and for each item a WHO

    certificate of quality control test results

    concerning quantitative assay, chemical analysis,

    sterility, pyrogen content uniformity, microbial

    limit, and other tests, as applicable to the Goods

    being supplied and the manufacturer's certificate

    of analysis;

    (b) Assay methodology of any or all tests if

    requested;

    (c) Evidence of bio-availability and/or bio-

    equivalence for certain critical Goods upon

    request. This information would be supplied on a

    strictly confidential basis only; and

    (d) Evidence of basis for expiration dating and other

    stability data concerning the commercial final

    package upon request.

    5.2 The Supplier will also be required to provide the Purchaser

    with access to its manufacturing facilities to aspect the

    compliance with the GMP requirements and quality control

    mechanisms.

    Sec. VI-3

Report this document

For any questions or suggestions please email
cust-service@docsford.com