2 Overview Introduction Scope The Different Responsibilities Requirements for Record RetentionRequirements for Retention Periods
3 1. IntroductionThe retention period for Documents and Records must be in compliance with applicable regulations, Good Manufacturing and Distribution Practices (GMP and GDP).
4 2. ScopeThis scope applies to all GMP documentation and records, regardless of format or media, associated with pharmaceutical productsThis scope applies to all pharmaceutical manufacturing sites, affiliates and its subcontractorsIf the local requirements are more stringent than those defined in this presentation, then it must be adapted to take into account the regulation of each country.
5 4. Responsibilities (1)Site Management is responsible to ensure that the facilities and equipment are available to comply with this presentationSite Quality Management is responsible to ensure that there are retention systems and procedures in place to comply with this presentationThe site information systems resources are responsible for ensuring the retention and integrity of the electronic GMP documents, when electronic records are stored.
6 4. Responsibilities (2)It is the joint and mutual responsibility of Site Quality Management and Site Management to ensure that GMP documents are identified, retained, and archivedLocal procedures must define the specific responsibilitiesIt is the responsibility of each department to ensure the control and retention of GMP documents in accordance with the systems and procedures.
7 Requirements for Record Retention (1) Archived Documentation must be stored in a secure manner (e.g. fire/waterproof)Access to the archives must be restrictedNo information must be lost during the defined retention periodSecurity administration, access and control procedures must be specified for electronic systems.
8 Requirements for Record Retention (2) Original documentation must be managed in a controlled mannerAs required, authenticated documents/records such as photocopies, microfilm, microfiche, electronic, or other accurate facsimiles of the original documents and records must be managed in a controlled mannerArchiving may be subcontracted providing that a quality assessment confirms that the requirements of this presentation are satisfied.
9 Requirements for Record Retention (3) Where reduction techniques such as microfilming or electronic records are used, retrieval equipment and a means to produce a hard copy must be readily availableThe process of conversion to another format must be qualified/validated and the evidence to support this conversion must be managed in a controlled manner.
10 Requirements for Record Retention (4) During the retention period, originals or copies of records must be readily available at the establishment where the activities described in such records occurredRecords that can be retrieved from another location by electronic or other means are acceptable.
11 Requirements for Record Retention (5) There must be systems and procedures in place to ensure timely retrieval of archived documents and recordsThere must be periodic checks to verify timely retrieval and readability. Schedules for the periodic assessment must be addressed in local procedures or by procedures at the location where the activities occur.
12 Requirements for Record Retention (6) Documents and records that are no longer required because of the applicable record retention requirements, must be removed from the system and destroyed (e.g. deleted)Local procedures or procedures at the location where activities occur, must address the disposal of documents and records, which must be managed in a controlled manner to maintain company confidentiality.
13 Requirements for Record Retention (7) The information/data contained in documentation remains in perpetuity the property of the company even if the site or location is no longer the property of the company, unless specified in the contractIn case of closure or sale of a facility, provisions must be made to transfer all GMP Documentation to a new site or secured storage area.
14 Requirements for Record Retention (8) When microfiche or microfilm systems are used, equipment necessary to read the archives must be available on-siteThe site Quality Unit must certify the conformity of copies to the original recordThe accuracy and precision and resolution of the scanning process of paper documents must be verified.
15 Requirements for Record Retention (9) Provided the content and meaning of the electronic record is preserved, such records may be archived to non-electronic media such as microfilm, microfiche, and paper, or to standard electronic file format, such as PDF or other formats (i.e. - XML) identified by the company as meeting the requirements of this presentationTraceability to original hard-copy documents or files must be available.
16 Requirements for Retention Periods (1) Retention periods must be specified in local procedures (SOPs) in accordance with regulatory and legal requirementsRecords must be retained according to the strictest (i.e. longest retention period) requirements that applies.
17 Requirements for Retention Periods (2) All GMP production, control and distribution records must be retained for at least one year after the expiry date of the drug product batch (cGMP requirements)For APIs, all records must be retained for at least the expiry or retest date or maximum time period to use plus 6 (six) years to cover the potential maximum shelf-life of 5 (five) years for the drug product using this API.
18 Requirements for Retention Periods (3) For the associated raw materials and packaging components of APIs and drug products, the above mentioned document retention periods identified for APIs and drug products also apply.Raw Material: any substance, active or inactive, of a defined quality used in the manufacture of bulk materials, intermediates or finished products, whether or not it is present in the finished product. Covers items such as solvents, capsule shells, tablet coating ingredients, tablet printing inks, etc.
19 Requirements for Retention Periods (4) For legal reasons GMP documents must be retained for a minimum of 10 (ten) yearsThis retention period applies to all documentation associated with the manufacture of productBe aware of the differences : GMP requirements vs legal requirements
20 Requirements for Retention Periods (5) Examples of such documentation :Product batch records and associated raw dataRaw material and packaging materials records & associated raw dataDistribution dataPersonnel training recordsSpecificationsAnalytical methodsCertificates of AnalysisMaster batch records (manufacturing and packaging)
21 Requirements for Retention Periods (6) Examples of such documentation :Equipment and building recordsQualification and validation records/reportsCalibration and environmental control recordsSOPsAudit reportsDevelopment documentationTraceability records (components and products)Complaints
22 Requirements for Retention Periods (7) For non-product specific Standard Operating Procedures (SOPs), the two previous versions must be retained. In addition, a history file detailing all changes to the Standard Operating Procedure (SOP) must be retainedQualification and validation documentation and records including documentation and records that may be required by the regulatory authorities must be maintained throughout the lifecycle of a product, and at least 1 (one) year after the expiry date of the last manufactured product to which the documentation is related.
23 Requirements for Retention Periods (8) Longer retention periods may be required for certain toxic products pursuant to labour lawsThe investigational batch records as well as the batch records supporting a submission to a health agency, and the associated raw data, must be retained 20 (twenty) yearsThe health agencies inspection reports, the inquiry reports (if appropriate), as well as recall files must be retained 20 (twenty) years.
24 SummaryIt is the joint and mutual responsibility of site Quality Management, and Site Management to ensure that GMP documents are identified, retained and archivedLocal procedures (SOPs) must define the specific responsibilitiesIt is the responsibility of each department to ensure the control and retention of GMP Documents in accordance with the systems and procedures.
25 ReferencesEU Good Manufacturing Practices, annex 11 – Computerised systemsEU GMP Part II (ICH Q7) – Good Manufacturing Practices for Active Pharmaceutical Ingredients, §5.4 Computer Systems;21 CFR part 11 – Electronic Records, Electronic Signatures, Final Rule;August 2003 FDA Guidance – Electronic Records, Electronic Signatures, Scope and Application;21 CFR Part 820 Medical Device – Quality System Regulation