1. Purpose
The purpose of this International Guideline is to describe the principle of handling the quality assessment and recovery of returned goods.
2. Scope
This International Guideline is applicable to all materials e.g. Active Pharmaceutical Ingredients, Bulk Formulated Products and Finished Packs that have been returned to warehouses and distributors directly controlled by the manufacturing site. Materials and products to be used in R&D activities are not within the scope of this guideline.
3. Definitions
3.1 Returned Product
A product or pack that has been sent back from a receiving site or customer. This could be due to a number of reasons, for example, ordering error, shipping error, suspected defect.
3.2 Quality Assessment
A critical and documented evaluation of the quality of returned products.
4. Responsibilities
4.1 It is the responsibility of each site to put in place procedures that describe the process for the evaluation and recovery of returned goods.
4.2 It is the responsibility of the local function responsible for product release to determine whether returned goods should be accepted into stock.
4.3 It is the responsibility of the appropriate departments to provide Quality Assurance/Quality Control with the necessary information to make the final decision on the disposition of the returned material. Failure to provide the required information within a reasonable timeframe will result in the material being sent for destruction.
5. Guideline
5.1 Returned Goods
5.1.1 Products that once have left the direct supervision of the company, its joint ventures, licensees or contractors and have been returned should generally not be accepted for redistribution and should normally be destroyed. However, if traceability and control of the product according to the required storage and transportation conditions can be confirmed, products may be re-distributed on approval by the QA function, (see 5.1.6).
5.1.2 The transportation of the returned goods shall be handled according to company’s transportation guidelines, including temperature monitoring.
5.1.3 If returned goods suffer from quality defects or non-conformities complaints procedures shall be applied and the returned product shall not be placed back into stock. Following the investigation all materials shall be destroyed.
5.1.4 If the frequency of returned goods becomes high, an investigation should be made in order to identify the technical or administrative causes and to take necessary corrective action.
5.1.5 Returned goods shall be clearly labeled as such, on receipt at the site and segregated from other stock. If a validated computerized storage system is used this segregation does not need to be physical, unless the returned goods falls under section 5.1.3. Where stock is returned from multiple sources, the stock from each source should be independently stored, i.e. the stocks should not be combined to form a batch.
5.1.6 Returned goods should only be considered for redistribution, reworking or repackaging after they have been critically assessed by the responsible Quality Assurance Department according to a written procedure.
5.1.7 Where a Product Lead Site is nominated, samples should be sent to the Product Lead Site for analysis if appropriate as part for the assessment described in clause 5.1.9.
5.1.8 If the material has been released under EU QP-release. The QP responsible for the original release shall approve the assessment according to 5.1.9.
5.1.9 Dependent upon the nature of the return the assessment should include the following points:
– The name and strength (potency) of the product;
– The date of return and the reason for the return;
– The source of the returned goods;
– The nature of the returned goods and specific storage and transportation conditions it requires;
– The condition and history of the returned goods. The primary seal and packaging should be intact. If the primary seal is broken or has been resealed the returned goods should be destroyed;
– The time elapsed since the material originally left the site and its subsequent storage, transportation and handling;
– The available shelf life of the returned goods;
– An assessment of damage or external contamination;
– A review of the quantities of product originally released and subsequently returned to determine any abnormalities in reconciliation;
– Review of batch protocol for previous returns.
The assessment should include the following points when appropriate:
– Analysis of the material to determine compliance with specification by the Lead Site (where it exists), or by the manufacturing site (if there is no Lead Site);
– The stability profile of the product; and a comparison of the analytical results on return and on release;
– The Lead Site should confirm the result of the analysis.
5.1.10 Product should only be considered for redistribution, reworking or repackaging if the examination, testing or other investigations outlined above prove the drug meets appropriate standards of safety, strength and quality.
5.1.11 All actions, inspections and analysis shall be documented, and shall ensure traceability to the original batch.
5.1.12 If the assessment confirms the quality of the product, the product can be re-released for redistribution, reworking or repackaging using the defined QA and site procedures.
5.1.13 Reworking or repackaging operations shall be carried out in compliance with the regulatory application by the unit originally responsible for the operation.
5.1.14 If reworking or repackaging operations are not performed at the unit originally responsible for the operations, the operations should be performed in a facility approved by International Compliance Group, QA & Dossier Management, Manufacturing Strategy Group or the Lead Audit site.
5.2 Salvaged Goods
5.2.1 Returned goods that have been subjected to improper storage and/or transportation conditions, including extremes in temperature, humidity, smoke fumes, pressure, age, or radiation due to natural disasters, fires, accidents or equipment failures shall not be salvaged or returned to the market place.