Manufacturing and ISO 22716

In brief

Manufactured in conformity with ISO 22716 cosmetic GMP guidelines. A Supplier's Declaration of Conformity issued in accordance with ISO/IEC 17050-1 is available to professional accounts.

Where the products come from

Vegalab S.A. is a Swiss biotechnology company, at Aegeristrasse 5, 6300 Zug, Switzerland. Beauty Science formulas and the NanoVeil encapsulation platform are developed there. The platform's origin is described on Swiss developed.

What ISO 22716 covers

ISO 22716 is the international guideline for good manufacturing practice in cosmetics. It sets out how a cosmetic is made, controlled, stored and shipped so that each lot matches its specification. It covers:

• Personnel. Defined responsibilities, training and hygiene.
• Premises and equipment. Layout, cleaning, maintenance and calibration.
• Raw materials and packaging. Purchasing, receipt, identification, testing and storage.
• Production. Documented instructions for each step, with records of what was done.
• Finished products. Release, storage, shipment and returns.
• Quality control. Sampling, testing, and retention of samples.
• Out-of-specification results and deviations. How each is investigated and closed.
• Complaints and recalls. How each is logged, investigated and acted on.
• Change control, internal audit and documentation. How the system itself is kept current.

In the European Union, Regulation (EC) No 1223/2009 requires cosmetics to be manufactured in compliance with good manufacturing practice, and ISO 22716 is the standard used to show it.

What a Supplier's Declaration of Conformity is

A Supplier's Declaration of Conformity is a formal statement, issued and signed by the manufacturer, that a product, process or management system conforms to named requirements. The format is set by ISO/IEC 17050-1. Its supporting documentation is kept in accordance with ISO/IEC 17050-2, so every statement in the declaration can be traced to a record.

The declaration names:

• the issuer and its address;
• the object of the declaration, here the Beauty Science manufacturing process;
• the requirements it conforms to, here ISO 22716;
• the date and place of issue;
• the name and function of the person who signed it, on the issuer's behalf.

A declaration is the manufacturer's own attestation. Its value lies in the documentation behind it, which professional accounts can request through professional documentation.

What happens at the fill

The vials and stoppers are sterilized before filling. Each ampoule is filled and sealed immediately under a butyl stopper and a 20 mm aluminum crimp with a flip-off cap. The serum is a preserved cosmetic formulation. How the format works in use is set out on the sealed vial format.

Every carton carries its expiry date and lot number. The lot number links each carton to its batch record.

How manufacturing connects to testing

Conformity to ISO 22716 governs how each lot is made and recorded. How preservation and microbial quality are assessed is explained on the testing program. The commitments the two serve together are in the quality charter. Where products stand with regulators in each market is on regulatory status.

Related

The science hub sets out who is responsible for Beauty Science formulation and review. For distribution partners, the declaration and supporting documents form part of the distributor documentation set.