Quality Agreement Between Altea Farmacéutica

and <Manufacturer name>

Product Name LubKlear 70 NF SAP Code

Supplier Name SAP Code

Supplier Address

Manufacturer Name

Manufacturer Address

1. Certifications
ISO 9001 X Yes □ No If yes, please attach it.
ISO 14001 □ Yes X No If yes, please attach it.
Supplier
GMP □ Yes X No If yes, please attach it.
FDA □ Yes □ No
ISO 9001 X Yes □ No If yes, please attach it.
ISO 14000 □ Yes □ No If yes, please attach it.
Manufacturer
GMP □ Yes X No If yes, please attach it.
FDA X Yes □ No

2. Raw Material Information

Commercial name LubKlear 70 NF

Expiry period 18 months from date of manufacture

Pharmacopeia compliance (PE, USP…) □ PE X USP □ JP

CEP (Certificate of suitability to the European Pharmacopeia) □ Yes X No Reference CEP :

X Pharma X Food/FCC X Cosmetic
Purity Grade
□ Other, Which? ____________________

DMF (Drug Master File) □ Yes X No Reference DMF :

Traceability visible on : Packaging labels X Yes □ No check doc attached:

Conformity certificate □ Yes □ No check doc attached:

Shipping certificate □ Yes □ No check doc attached:

Certificate of analysis X Yes □ No check doc attached:

Complete Traceability of your raw materials X Yes □ No check doc attached:

Sanitary safety : status of your raw material □ Animal □ Vegetal X Mineral □ Synthetic

IT system : 21 CFR Part 11 X Yes □ No

Lab : internal performance of 100 % of your analysis □ Yes X No

If not, name of your lab sub-contractors under contract ISO 17025 Certified Lab – Maxxam Analytics

□ Yes X No
Back up production site
If yes, location :

F-ASC-033 version 4.0 corresponds to PSO-ASC-063

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3. Packaging information

Type and size of the packaging Steel drum with epoxy lining

Quantity per packaging unit Variable on order

Documents mandatory with each delivery Bill of lading, COA,

Batch size

Normal Supply timeline Two to eight weeks

Supply timeline in Worth case

Seals on packages X Yes □ No

4. Documents requested

1 Technical specifications Version and validity date : 3 / July 2018 see document attached

2 Safety Data sheet Version and validity date : 6 / July 2018 see document attached

Version and validity date : September 2018 see document

3 TSE-BSE certificate
attached

5. Responsibilities

Object : The table hereafter indicates the separation of responsibilities between the manufacturer, the supplier and the
customer for the mentioned item :

SUPPLIER ALTEA COMMENTS

Compliance follow-up ✓
Specifications definitions ✓
Production organization ✓
Batch numbers ✓
In Process controls ✓
Manufacturing records ✓
Manufacturing documentation review ✓
Quality control before release ✓
Packaging operations of raw material
Product release ✓
Legal’s samples ✓
Customer’s sample ✓
Certificate of Analysis ✓
Release before shipping ✓
Equipment’s validation and qualification ✓
Manufacturing process validation ✓
Stability studies (only for API) ✓
Shipment to Altea o distributor ✓
Storage specifications ✓ ✓
Identification at reception ✓
Control of the raw material ✓
Release before using ✓
Investigation in case of complaints (e.g. out of ✓ ✓

F-ASC-033 version 4.0 corresponds to PSO-ASC-063

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 specification, …)

6. Commitments
➢ The supplier should inform Altea Farmacéutica of any modification (change control) before
implementation, of any mistake or out of specification result could have an impact on the quality of
finished products.
➢ The supplier should inform of any inspection of the installations and results, could have an impact
on the quality of products manufactured by Altea Farmacéutica
➢ The supplier should inform Altea Farmacéutica any change in location of manufacturing site or
shortage of the raw material.
➢ All sub-contractors should be approved by the supplier and inform to Altea Farmacéutica
➢ The supplier allows Altea Farmacéutica to perform audits
➢ All complaints will be addressed to the QA contact who signs the present document

« Altea Farmacéutica commits to consider the collected information as confidential and to

disclose them only to reply to some eventual regulatory provisions »

MANUFACTURER ALTEA

Name Pablo Davila

Position Business Development

Company LUB-LINE

Date December 3, 2018

Signature

Version Change

01 New document

F-ASC-033 version 4.0 corresponds to PSO-ASC-063

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