Novo Nordisk Internal no.

: NNID/QA/05/04
Document no.: 104082
Edition: 1.0

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Instruction

NNID Repackaging of Marketed Novo Nordisk Products

Applies to Supersedes -
Matrix : 779
Section : NNID Copy no. -
ISO subject : 1500
Code : -

Encl.
-

Prepared by department no.: 779

NNID QA
(date) Nia Jelantik (NRHJ) Jnr Product Manager

Approved by:

NNID Management
(date) Richard R. Breurkes (RRUB) General Manager

NNID QA Release.
(date) Nia Jelantik (NRHJ) Jnr Product Manager

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 Novo Nordisk Internal no.: NNID/QA/05/04
Document no.: 104082
Edition: 1.0

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Table of contents
1 Purpose ................................................................................................. 2
2 Scope .................................................................................................... 2
3 Responsibility ........................................................................................ 3
4 Abbreviations......................................................................................... 3
5 Definitions.............................................................................................. 3
6 Procedure.............................................................................................. 4
6.1 Evaluate Repackaging Needs........................................................ 4
6.2 Process documentation requirements............................................ 4
6.3 Preparation for Repackaging ......................................................... 4
6.4 Repackaging plan approval............................................................ 5
6.5 Repackaging Processing ............................................................... 5
6.6 Release of Repacked Product ....................................................... 5
7 References ............................................................................................ 5

1 Purpose
To describe the requirements of the process and documentation when NN
products need to be repacked in Indonesia.

2 Scope
This procedure only applies to repackaging performed in Indonesia.

This SOP applies to the following products:

• Finished products imported by distributors
• Modification to the secondary packaging materials for marketing
purpose

This SOP does not apply to the repackaging of any clinical trial products.

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Edition: 1.0

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3 Responsibility

NNID QA • Ensure content of repackaging plan is in compliance

with ref. 1
• Control the process of Repackaging
• Evaluate if Product Specific requirement is met (ref. 2)
• Use approved location for Repackaging
• Evaluate if the packaging materials for Repackaging is
correct and approved
• Evaluate if the Repackaging documentation is proper
and correct

NNID/ RA • Handle relevant regulatory issue of Repackaging

• Ensure relevant approval from authority is received
• Ensure correct Repackaging material are used

4 Abbreviations

Abbreviation Description

NN Novo Nordisk

IQS International Quality Support

NNID PT Novo Nordisk Indonesia

QA Quality Assurance

RA Regulatory Affairs

5 Definitions
Repackaging – The removal, addition to or modification of secondary
packaging materials (e.g. inserts, labels, cartons and stickers, incl. price
stickers).

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 Novo Nordisk Internal no.: NNID/QA/05/04
Document no.: 104082
Edition: 1.0

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6 Procedure

6.1 Evaluate Repackaging Needs

Repackaging should be avoided whenever possible

Logistics should evaluate if it is possible to import products that do not need to be

repacked.

6.2 Process documentation requirements

• Repackaging Plan (ref. 1)

• Batch Documentation (ref. 1)
• Availability of surplus time for repackaging at room temperature
• Approval of packaging materials used for repackaging

6.3 Preparation for Repackaging

6.3.1 Product Quarantine

Products need to be repacked should be clearly marked and separated from the
other products. Products should be quarantined and stored in the environment or
proper light, temperature and humidity before repackaging until products is
approved for release.

6.3.2 Location

Repackaging could be performed in the distributor warehouse and/or other

subcontractors approved for the activity by QA.

6.3.3 Preparation and Control of locally printed packaging materials

Packaging materials should comply with Handling of Locally Printed Packaging

Materials (ref. 3).

6.3.4 Repackaging Plan

NNID QA should record all relevant information in ref. 1.

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 Novo Nordisk Internal no.: NNID/QA/05/04
Document no.: 104082
Edition: 1.0

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6.4 Repackaging plan approval

Except situation stated in Doc. No. 015617, Section 6.1.4.1, (ref. 1), NNID QA
should submit the Repackaging Plan to IQS for approval. After IQS approval the
repackaging is sent to Site QA for approval.

6.5 Repackaging Processing

Repackaging can only be processed after QA approval.

NNID QA is responsible for controlling the process of Repackaging.

Every batch of products should have its Batch Documentation. Only one batch of
product can be repacked at a single time.
Product stated in the repackaging plan must be repacked in one continuous
operation, unless otherwise approved by IQS and site QA.

The area and line must be cleared prior to and after each repackaging

Batch documentation must be filled-in at the time of each operational step and
approved by the person responsible for the repackaging operation.

In case of deviations from:

• The approved repackaging plan
• cGMP
• Applicable instructions and procedures
The local quality responsible person must initiate a nonconformity which must be
handled according to the local procedure.

6.6 Release of Repacked Product

NNID QA should evaluate and approve the Batch Documentation and submit to
site QA for approval, except for situation stated in Doc. No. 015617, Section
6.1.4.1. (ref. 1).

After approval by site QA, NNID QA should inform NNID Logistics, distributors or
subcontractors that batch of products could be released for sales.

The fate of rejected product must be decided in cooperation with the site QA and/or
IQS and disposition of the product adequately documented.

7 References
1. Doc. No. 015617, Repackaging of Marketed Novo Nordisk Products
2. Doc. No. 040747, Handling, storage, Packaging, Preservation and Delivery of
Novo Nordisk Products
3. Doc. No. 101056, Handling of Locally Printed Packaging Materials

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 Novo Nordisk Internal no.: NNID/QA/05/04
Document no.: 104082
Edition: 1.0

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Change Log
Ed. Effective date Reason for revision Revised without
changes
Date / Sign.

1.0 New [CR2004-02]

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