Objectives

The primary objective of this tender is to procure inserts for Black Quarter vaccine, specifically 20,000 units of 100ml inserts, to meet the specifications provided by Onderstepoort Biological Products Ltd. The procurement aims to ensure the supply of quality packaging inserts that comply with regulatory and technical standards.

Scope

The scope of the tender includes:

• Provision of 20,000 inserts for Black Quarter vaccine (Item Code: PI 1056).
• Adherence to detailed packaging and labeling specifications, including size, material, barcoding, and registration requirements.
• Supply of packaging inserts grouped into bundles of 300 leaflets, packed into inner boxes with labels, and shipped in shippers with appropriate labeling.
• Provision of Certificates of Conformance and Quality Assurance approvals as specified.

Technical Requirements

The technical specifications for the inserts include:

• Size: 32 mm (L) x 130 mm (W) (± 1.0 mm) when folded.
• Material: 55 micron thickness paper (range 52-60 micron), uncoated, white in color.
• Barcoding: Affixed on the top of the insert as per drawing, including the Namibian Registration number V01/24.4/161.
• Supplier identification: Indicated at the bottom of the insert.
• Packaging: Each bundle contains 300 leaflets, wrapped with paper, packed into inner boxes with labels indicating supplier name, insert package name, batch number, and quantity (grouped into 50s).
• Shipper: Must have a label with a printed sample of the packaging insert attached outside, and include a Certificate of Conformance (C of C).
• Additional: The insert must include the reference number, house test results, and use consistent terminology as per the approved artwork and drawing.

Skills and Skills Requirements

The supplier must demonstrate:

• Experience in manufacturing pharmaceutical packaging inserts, with proof of previous supply of similar items within the last 24 months (stamped invoices, delivery notes, or reference letters).
• Capability to produce inserts that meet detailed technical and regulatory specifications, including size, material, barcoding, and registration requirements.
• Compliance with quality assurance processes, including submission of Certificates of Conformance and Quality Assurance approvals.
• Ability to provide accurate and consistent artwork, including proofing and approval processes.
• Knowledge of packaging and labeling standards for pharmaceutical products, particularly vaccines.
• Provision of a valid BBBEE certificate (if applicable) and CSD report not older than 2 months for South African companies.