Follow
OBJECTIVE : To provide information regarding the tamper evidence features appropriate for various types of packs.
SCOPE : This procedure is applicable to all product packs in (Company Name).
RESPONSIBILITY :
It is the responsibility of QA Department, to follow the instructions as stated in this procedure.
It is the responsibility of QA Department for revision, control, implementation & management of this SOP in due time.
ACCOUNTABILITY : Head of Quality.
PRECAUTIONS: NA
PROCEDURE :
1. Recommended options for tamper evidence
All products should be assessed individually to identify the degree of risk and to determine the most suitable tamper evidence features.
Temper evident features should be clearly identifiable as a BPL feature either by printing a trade mark or by using a feature style unique to BPL. This makes illicit replacement by new component more difficult.
2. Tamper evident features for cartons
Where a tamper evident feature is applied to cartons use one or more of the following:
Option 1: Identified label seals, tape seals or destructible seals, hologram.
Option 2: Identified over wraps or any other secure means of sealing the carton.
Note: Use glue-ended cartons only if the primary pack is inherently tamper evident as a means of destroying or defacing the carton to prevent reuse. The cartons should be designed so that the glued tabs cannot be separated by use of blade or heater and the separated tabs cannot be re-glued without being obvious.
3. General considerations for tamper evident features
All tamper evident features should be designed to prevent their removal and reuse.
Label Seals and Tapes depend for their effectiveness on the adhesive used. The adhesive effectiveness should be checked thoroughly for each application, to
ensure that they cannot be removed without it being obvious e.g. fiber tears of the carton substrate.
Tamper evident closures should be selected so that:
– Removal by the end user is easy (where appropriate).
– Replacement of the closure, after initial removal, leaves an indication that it has been opened.
4. Statement identifying the tamper evident feature
A statement should be displayed on the pack in a position close to the feature and should clearly indicate to the user if the pack is intact.
Example: Carton Seal: Do not accept if security seal is missing or broken.
