Transcript Company name DEPARTMENT Quality Systems

GMP Document and
Record Retention
Overview
• Introduction
• Scope
• The Different Responsibilities
• Requirements for Record Retention
• Requirements for Retention Periods
1. Introduction
The retention period for Documents and
Records must be in compliance with
applicable regulations, Good
Manufacturing and Distribution Practices
(GMP and GDP).
2. Scope
• This scope applies to all GMP documentation and
records, regardless of format or media, associated with
pharmaceutical products
• This scope applies to all pharmaceutical manufacturing
sites, affiliates and its subcontractors
• If 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.
4. Responsibilities (1)
• Site Management is responsible to ensure that the
facilities and equipment are available to comply with this
presentation
• Site Quality Management is responsible to ensure that
there are retention systems and procedures in place to
comply with this presentation
• The site information systems resources are responsible
for ensuring the retention and integrity of the electronic
GMP documents, when electronic records are stored.
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 archived
• Local procedures must define the specific responsibilities
• It is the responsibility of each department to ensure the
control and retention of GMP documents in accordance
with the systems and procedures.
Requirements for Record
Retention (1)
• Archived Documentation must be stored in a
secure manner (e.g. fire/waterproof)
• Access to the archives must be restricted
• No information must be lost during the defined
retention period
• Security administration, access and control
procedures must be specified for electronic
systems.
Requirements for Record
Retention (2)
• Original documentation must be managed in a controlled
manner
• As 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 manner
• Archiving may be subcontracted providing that a quality
assessment confirms that the requirements of this
presentation are satisfied.
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 available
• The process of conversion to another format must be
qualified/validated and the evidence to support this
conversion must be managed in a controlled manner.
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 occurred
• Records that can be retrieved from another
location by electronic or other means are
acceptable.
Requirements for Record
Retention (5)
• There must be systems and procedures in place
to ensure timely retrieval of archived documents
and records
• There 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.
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.
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 contract
• In 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.
Requirements for Record
Retention (8)
• When microfiche or microfilm systems are used,
equipment necessary to read the archives must be
available on-site
• The site Quality Unit must certify the conformity of
copies to the original record
• The accuracy and precision and resolution of the
scanning process of paper documents must be verified.
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 presentation
• Traceability to original hard-copy documents or
files must be available.
Requirements for Retention
Periods (1)
• Retention periods must be specified in local
procedures (SOPs) in accordance with regulatory
and legal requirements
• Records must be retained according to the
strictest (i.e. longest retention period)
requirements that applies.
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.
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.
Requirements for Retention
Periods (4)
• For legal reasons GMP documents must be
retained for a minimum of 10 (ten) years
• This retention period applies to all
documentation associated with the manufacture
of product
• Be aware of the differences : GMP requirements
vs legal requirements
Requirements for Retention
Periods (5)
• Examples of such documentation :
 Product batch records and associated raw data
 Raw material and packaging materials records &
associated raw data
 Distribution data
 Personnel training records
 Specifications
 Analytical methods
 Certificates of Analysis
 Master batch records (manufacturing and packaging)
Requirements for Retention
Periods (6)
• Examples of such documentation :
 Equipment and building records
 Qualification and validation records/reports
 Calibration and environmental control records
 SOPs
 Audit reports
 Development documentation
 Traceability records (components and products)
 Complaints
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 retained
• Qualification 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.
Requirements for Retention
Periods (8)
• Longer retention periods may be required for certain
toxic products pursuant to labour laws
• The 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)
years
• The health agencies inspection reports, the inquiry
reports (if appropriate), as well as recall files must be
retained 20 (twenty) years.
Summary
• It is the joint and mutual responsibility of site Quality
Management, and Site Management to ensure that GMP
documents are identified, retained and archived
• Local procedures (SOPs) must define the specific
responsibilities
• It is the responsibility of each department to ensure the
control and retention of GMP Documents in accordance
with the systems and procedures.
References
• EU Good Manufacturing Practices, annex 11 – Computerised
systems
• EU 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
Thank You
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