Creating a Standard Operating Procedure SOP for Pharmaceuticals Record and Data Management is essential to ensure compliance with regulatory requirements and maintain the integrity of critical data. Here’s a template to help you develop an SOP tailored to pharmaceuticals. Adjust it according to the specific needs and processes of your pharmaceutical organization.
A. QA Officer
- Verifies adequacy and accuracy of forms and worksheets used in the area
- Reviews report packets for completeness
- Ensures employees are trained in record keeping
- Responsible for using the proper and approved forms and worksheets,
- Responsible for following record management guidelines, and
- Securing records (i.e. placing in locked cabinets) when in their possession.
B. Sr. QA Officer
- Implements record management system in respective branch
- Ensures proper forms and worksheets are used in respective departments
- Follows by the establishment records storage or disposal scheduled.
C. Assistant Manager QA
- Ensures implementation of a record management system
- Ensures storage areas for records are within resources
- Periodically assess the effectiveness of the record management system.
D. Manager Quality Assurance (MQA):
- Maintains record system for quality records
- Archives and disposes of quality records as established by record schedule.
- Background None
- References Staff Manual Guide FDA 2460, Management Programs, Records Management.
- Procedure for identifications/collections/indexing/accessing/filings/storageing/maintenance and disposals.
A. Record Identification
- Records are identifiable to the firm, product, person or event to which they pertain.
- Records are dated and identify the person who established the record.
B. Recording and Error Correction
- All work performed is recorded legibly. Work is recorded in such a manner than another individual, competent in the same field, may repeat the work described solely from the description written without additional explanation.
- Entries contain the date, initials of person performing the work, signed and dated.
- Entries are made in ink. No erasures are made. Space not used will be indicated with a line.
- Corrections will be made by drawing a single line through the incorrect entry, enter the correct information, initial and date the change.
- Data or information is not discarded without explanation. To discards, by data and information’s are crossing out, initial ding, dated or the reasons and discarding by the indicated.
C. Electronic Records
- Electronic records and data files are backed up on a regular basis to safeguard against the loss of information due to equipment malfunctions or human error. Instrument backups are noted on the respective Function Verification and Preventive Maintenance sheet.
- If applicable backups for the database in the Records Management Center (QA) onto CD media are performed daily, weekly and monthly.
- External labels of disk and diskettes or CDs are labeled to facilitate accurate filing and retrieval of electronic records. Examples of information that may be included on the label are:
- Subjects and functionals titles which is the identifies by the information,
- Inclusive/dates are information’s contaminated by disketteses or CDss.
- Identification by software’s programs by use to access’s of the all information.
- There is restricted access to all records to prevent unauthorized use and amending of information.
- Access to the documents is restricted to authorized personnel or escorted visitors.
- Records are returned during normal business hours to principal custodian or alternates.
- Records to be filed in the Master Documents Files for respective Departments are secured in the room at all times. This includes records that have been returned.
- Electronic records have password or field protection, or read-only capabilities.
E. Filing and Storage
- Records are stored in dry and clean rooms. Storage areas and cabinets are labeled. Record or other quality document should not store by the private desk drawers and obscuring by location that is not generally is knowns.
- Records pertaining to completed inspections and applications are filed in the [Location].
- Records are filed by the regulatory officer and QA officer (e.g. sample identification number).
- Quality records (e.g. audits, archived procedures and work instructions, corrective action and problem reports, function verification and preventive maintenance charts) are filed in the Asst. Manager Quality Assurance Manager’s office.
- Analytical worksheets are returned to the home district and stored by the analyzing laboratory in general.
F. Record Charge-Out
- To charge out a record.
- Records that are charged out are kept on the premises and kept secured in record.
- To transfer a charge-out record, the file is returned and then transferred to the requested person.
G. Record Retention
- The retention period will not be less than five years or as governed by regulation or policy. Quality records will be retained for a minimum for three years.
- Reports will be stored in a secure location with limited access. Computer based files are archived and stored for record keeping.
- The following information should be available in laboratory data files:
- date, place, time of sampling and name of person who collected,
- identification of sample as to whether it is a routine or check sample,
- date of receipt of sample and date of analysis,
- laboratory and persons responsible for performing analysis,
- analytical technique and method used and quality control data
- results of analysis.
H. Disposal of records
- Super ceded and outdated laboratory operating procedures and work instructions (controlled copies) are archived as replaced. Archived hardcopy records are marked “ARCHIVED”, dated and filed for the remaining time of the retention period.
- The master list is updated and electronic files are moved to a directory titled “ARCHIVED SOPS”.
- Other Quality Records
- Quality records (e.g. audit reports, reviews, FV and preventive maintenance charts, quality control charts, corrective actions) are archived per calendar year. Only current year’s records are kept in the applicable areas.
- Definitions Data file – A data file is related numeric, graphic or textual information that is organized in a strictly prescribed form and format.
- Electronic record – An electronic record is information recorded in a form that only a computer can process. Electronic records include numeric, graphic and textual information.
- Form – A form is a document with a fixed arrangement of captioned spaces designed for entering and extracting prescribed information. Forms become a record once filled out.
- Non-record – Non-records are copies of memoranda or letters sent to an office or an employee for information only and for whose filing or maintenance no one in the office is responsible.
- Records – Records are materials created or received by an agency and that are preserved as evidence of the activities of the agency or for its information value.
- Technical records – Technical records are accumulations of data and information which result from carrying out tests or calibrations and which indicate whether specified quality or process parameters are achieved.
- Controlled copy – A controlled copy is a document that is numbered and issued to an individual, the contents of which will be updated after distribution with stamp as CONTROLLED DOCUMENT.
- Uncontrolled copy – An uncontrolled document is a document that is current at the time of issue but for which no attempt will be made to update it after distribution; document is marked “Uncontrolled Copy”.
Attachments Attachment A: Records Schedule
- Sample files: Laboratory 5 years, Destroy 5 years after action or analysis
- Control Documents and completed Analytical Worksheets: No Action Indicated 2 years Destroy 2 years after date of collection
- Training Records: Retain for life of Employee or 3 years after
- Subcontractor Qualification (Purchasing): 3 years destroy after 3 years
- Work Orders (Purchasing): 3 years Destroy after 3 years
- Audit Reports: 3 years Destroy after 3 years
- Management Review: 3 years Destroy after 3 years
- QA Calibration Records: 3 years Destroy after 3 years
- Corrective Action Reports: 3 years Destroy after 3 years
- Complaints and Comments: 3 years destroy after 3 years
- Method Validation: 3 years Destroy after 3 years
- Modifications (Lab Procedures and Work): 3 years Destroy after 3 years
- Instructions (QA/QC Charts): 3 years Destroy after 3 years
- Revision History: First issued