LAB-015 Archiving Laboratory Documentation

1. Retention and Disposal of Laboratory Documentation

1.1. Retention

1.1.1. GMP Documentation

GMP documentation belonging to the Laboratories shall be retained by the Laboratories whose responsibility it is to retain and dispose of such documentation. This retained GMP documentation shall not be accessible by unauthorised people.

GMP documentation should be readily available for inspection by regulatory authorities and internal audits.

1.1.2. Electronic Data

Data may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedures relating to the system in use shall be in place and the accuracy and accessibility of Data shall be checked.

Electronic data shall be readily retrievable into a written document.

2. Storage of Documentation

Laboratory documentation must contain the following information:

a. Name of document or explanation of what it is in reference to

b. Dates (e.g. date written or produced or range of dates that apply to the documents)

c. Batch number or document reference number (where applicable)

d. Disposal/expiration date

e. Other information as applicable (e.g. type of documentation, where documentation has been generated from)

All Laboratory documentation is to be stored onsite and accounted for at all times.

3. Disposal

3.1. Documents should be destroyed at the end of their appropriate retention period, this being a minimum of 13 years (See SOP QMS-010) or unless otherwise stated, from either a date of manufacture, date of release or date of Production/testing depending on the type of document.

3.2. Documents must be disposed of by shredding or incineration.

3.3. In the event of a third party contractor being used to dispose of documents, this contractor’s activities should have been inspected by QA personnel in order to determine acceptance or suitability.

4. Retention and Disposal of Laboratory Documentation

The Laboratory produces a large quantity of documentation which must be clearly labelled, stored and accounted for at all times for the duration of the documents retention period (minimum 13 years).

Documents are stored in either in laboratory safes or in the numbered well boxes with detailed reference.

4.1. Archiving system is predominantly a manually hand recorded system for recording of documentation and can only be traced by manually looking through logbooks to find information.

4.2.  All Analytical Laboratory documentation is to be kept for a minimum of 13 years (unless otherwise stated).  If in doubt about what documents must be retained, ask the Laboratory Manager or the QA Manager.

5. Laboratory Documentation Systems

5.1. Faulty/Rejected Material Reports

The Laboratory keep a copy of all Faulty/Rejected Material Reports (Raw Material Chemicals; Raw Material Packaging Materials/Components; Finished Good Rejected Product; Expired Product) that were sent to the Laboratory for signing.

5.2. Finished Good Certificates of Analysis

Manufactured Finished Goods are assigned a Certificate of Analysis, which is generated from an entry in the Finished Good Register (Form-250). Each batch is assigned a pre numbered Certificates of Analysis known as Lab number.  All tests and results are to be printed on the Certificate of Analysis. Export Certificates of Analysis are created from these certificates of analysis using the data recorded on each.  Trend cards (Form-265,260) are filled in prior to the Certificate of Analysis being filed.  All of these certificates of analysis are to be archived into numbers well boxes for long-term storage.  If results are required from any of these certificates of analysis, check the Trend cards first before retrieving the actual document.

5.3. Finished Good Register

All manufactured Finished Good products are entered into the finished good register.  These register records the following information: Lab No. (pre-printed number on the top of the finished good Certificate of Analysis), BPN no., Product Name, Code No., Manufacture Date, Container, Batch Size, Comments, Goods Booking Slip no, QA Signature and Date of when product was passed.

5.4. Raw Material Certificates of Analysis

Incoming Raw Materials are all assigned a Certificate of Analysis, which was generated from an entry in the Raw Material Register (Form-255).  Each batch was assigned Laboratory Batch Number as soon as it is received by warehouse (see SOP WAR-005). All tests and results were printed on the Certificate of Analysis. Trend cards were filled in prior to the Certificate of Analysis being filed (all chemicals and components except printed materials which had a sample attached to the Certificate of Analysis).  All of these certificates of analysis have been archived into numbered well boxes for long-term storage.  If results are required from any of these certificates of analysis, check the Trend cards first before retrieving the actual document.

5.5. Raw Material Register

All incoming Raw Materials are entered into the Raw Material Register (Form-255).  These registers recorded the following information: Lab. batch No., Item Description, Code, Quantity, No. of Labels, Manufacturer’s Batch No., Supplier, Order No., GRS (Goods Receipt Slip), QA signature and Date when product was passed.

5.6. Trend Cards

Trend cards are a good way to look back at results for specific products/codes.

There are two lots of manually recorded Trend cards:  Finished Goods and Raw Materials.

5.6.1. Finished Goods Trend Card (Form-260)

5.6.2. Raw Material Trend Card (Form-265)

6. Procedure for Archiving Documentation Long Term

6.1.  This is to be applied to all documentation that is to be kept for a set period of time, but not referred to on a regular basis.  All archived documentation is to be packed into well boxes and clearly labelled with contents, disposal dates and must be stored on site.

6.2. Each well box is to be given a number that is unique and distinguishes it from all other well boxes.  It must contain the letters ‘QA’, with a prefix L (Laboratory) and followed by either 2 or 3 digits e.g.

LQA017 is Laboratory Quality System Documents box number 17

6.3. Well number must be issued sequentially.

6.4. Documents are to be packed into smaller boxes of same size collected from warehouse and the contents filled out on the Laboratory and QA Documents Log Sheet and Box labels form (Form-270). After the boxes are registered in the form place them in the well box until there will be no spaces left.

6.5. Each smaller box is given a letter that distinguishes if from all other smaller boxes within the larger well box, e.g. H. The labels are printed from the Form-270 and stuck on the outside.

6.6. Once a smaller box is filled, the completed Laboratory and QA Documents Log Sheet is photocopied, with the copy being inserted into a plastic invoice slip and stuck on the outside of the corresponding box. The original copy of the completed Form-270 is kept in the designated Laboratory Cabinets. These completed forms are to be used for retrieving information at any time during the retention period.

6.7.  Once a well box is full of smaller boxes, the front panel is inserted and the lid put on.  The front panel must have the well box number e.g. LQA017 and Date to be Discarded.  These are to be written as large and legible as possible.

6.8.  Example of what should be written on the front panel of the well box:

6.9. When ready, the well box can be transported.  Complete a Warehouse Information Form (Form-015) and attach to the well box.  Ask the Warehouse staff to pick the box up and transport it to the Warehouse for storage.

7. Summary of Changes