MANAGEMENT OF RAW DATA
PURPOSE: To provide a procedure for recording, review and storage of raw data at manufacturing sites.
SCOPE: This SOP applies to all the raw data generated / collected during Warehousing, manufacturing/packaging operations, testing, environmental monitoring, operation and monitoring of equipment and utilities, calibrations, qualification and validation activities, cleaning, sterilization and any other activity, which involve recording of raw data, directly or indirectly affecting the product quality.
The SOP applies to the raw data recorded manually as well as which is acquired by electronic means at all the manufacturing sites (Intermediates, Drug Substances or Drug Products).
RESPONSIBILITY:
All the personnel engaged in Warehousing, Manufacturing, Testing, Maintenance, cleaning operations, Manufacturing support and Qualifications / Validation are responsible for accurately recording the raw data related to respective operation in the relevant document.
Head QA/Designee responsible for ensuring that systems and procedures are in place to document all the raw data and its storage as per requirements of Good Manufacturing Practices prescribed by various regulatory agencies and same are complied.
DEFINITIONS:
RAW DATA
Any data, readings, output generated by measurement systems, instruments which are either recorded manually by personnel observing the display, or stored by electronic means or printed directly from the instrument or system.
PROCEDURE:
Raw data in Warehouse:
Temperature /RH mapping data – This shall be recorded using data logger or data acquisition system or manually, areas described in the applicable qualification protocol. The temperature printouts obtained from data acquisition system/data logger or recorded manually shall be stored after review and approval by the concerned warehouse and Quality assurance personnel.
Environmental condition monitoring data -This shall be either recorded using data acquisition system or recorded manually at specified intervals according to the applicable SOP(s). The raw data shall include the temperature end where applicable % RH. When manual recording is done data logger capable of recording minimum and maximum reading in a day (24hours) shall be used to obtain the maximum variation observed during the day. The raw data shall be stored as printouts or manual records,
which shall be reviewed for correctness/ compliance to the predetermined acceptance criteria and signed by the designated warehouse personnel.
Pressure differentials monitoring data – Pressure differentials of the clean rooms, such as sampling room, dispensing rooms shall be recorded manually in pressure differential monitoring records. Printouts of the raw data shall be retained after review and approval by warehouse personnel.
Dispensing records – Dispensing records shall include the actual observations of the gross-weight, tare-weight and net-weight or the volume of the material dispensed. These weights/volumes shall be recorded in the batch manufacturing records by person dispensing the material and independently verified by person supervising the operation. Wherever the weighing scales are equipped with printing capability, weight printouts shall be checked and signed by the designated warehouse personnel. Al such printouts shall be used as raw data and become part of the batch record.
Raw data in Manufacturing/Packaging operation:
Environmental condition monitoring data – This shall be either recorded using data acquisition system or recorded manually at specified intervals according to the applicable SOP(s). The raw data shall include the temperature and where applicable % RH. When manual recording is done data logger capable of recording minimum and maximum reading in a day (24hours) shall -be used to obtain the maximum variation observed during the day. The raw data shall be stored as printouts or manual records,
which shall be reviewed for correctness/ compliance to the predetermined acceptance criteria and signed by the designated personnel.
Pressure differentials monitoring data – These shall be recorded manually in pressure differential monitoring records and reviewed/approved as per applicable SOP(s). The designated personnel shall retain printouts of the raw data after review and approval.
Weighing records – Weighing records shall include the verification of the gross weight of the dispensed materials issued from the store and the actual observations of the gross-weight, tare-weight and net-weight of the material at different stage of manufacturing. These weights shall be recorded in the batch manufacturing records by person weighing the material and independently verified by person supervising the operation.
Wherever the weighing scales are equipped with printing capability, weight printouts shall be checked and signed by the designated manufacturing personnel. All such printouts shall be used as raw data and become part of the batch record.
Process equipment/instrument parameter monitoring – The data related to monitoring of process parameters such as temperature, pressure, vacuum, speed/rotation etc. which varies as per product/process needs shall be recorded manually or by electronic means. Manual recording of the values as displayed on the instrument/ monitor fitted with the equipment shall be done in the batch manufacturing record. If there is capability for the printing, printouts of the raw data shall be retained and be attached in batch manufacturing record after review by designated personnel, in accordance with applicable SOP(s).
Results of in-process checks – In-process tests such as Disintegration Test, Friability, Leak test, Weight variations, pH, Conductivity, LOO, Filter integrity test etc. are carried out at specific time intervals during the manufacturing/packaging operation.
The readings/values/units, as displayed on the instrument/ monitor fitted with the instruments shall be recorded in the Batch manufacturing record/in-process sheet manually. If there is capability for printing, the printouts of the raw data shall be retained and be attached to the batch record after review by designated personnel, in accordance with applicable SOP(s).
All raw data related to in-process checks like weights, shall be checked and recorded in the batch record.
Raw data in Quality Control Laboratory:
Weighing Records – Weighing record of reagents shall include actual weight readings of the materials taken for use. These weights shall be recorded manually in the relevant test data sheet (TDS). Wherever the weighing scales are equipped with printing capability, weight printouts shall be checked, signed and used as raw data. The printouts shall become part of the test data sheet.
Instrument operating parameters – Instrument operating parameters such as temperature, pressure, vacuum, RPM etc. as displayed on the instrument/ monitor fitted with the instrument/equipment shall be recorded in the test data sheet used. If there is capability of printing, printouts of the raw data shall be retained separately or attach to the relevant document after review by the designated personnel.
Analytical Instrument Output – While performing the analysis using chromatography, spectrophotometry or Titrimetric methods etc., the response obtained· in the form of Chromatographs, Absorbance, titration readings etc. shall be printed and retained with the test data sheet after review by the QC personnel.
Temperature I Humidity monitoring – Temperature/ Humidity raw data of QC area, refrigerators, retention sample room and stability chambers shall be recorded using data logger or data acquisition system or manually and retained after it is reviewed by the designated QC personnel.
Raw data in Engineering
Operating parameters of utility equipment – Operating parameters of utility equipment such as temperature, pressure, velocity, etc. which varies as per requirements shall be recorded manually or by electronic means.
Manual recording of the values as displayed on the instrument/ monitor fitted with the equipment shall be done in the prescribed format as per the applicable SOP. The designated personnel shall retain where capability of printing is available, printouts of the raw data after review/approval.
Data related to checks performed to measure the performance of utility systems – Performance of the utility systems are checked at a definite interval as per the requirement and as described in the individual protocol/standard operating procedure. Different utility parameters such as air velocity, filter integrity, Non-viable particulate, air dryness, light intensity etc. are checked by using test instruments.
The readings/values as displayed on the test instrument shall be recorded in the prescribed format as per the applicable SOP. The designated personnel shall retain where printing capability is available, printouts of the raw data after review/approval.
Raw data in Calibrations
Actual input given to the test and standard instrument shall be recorded in addition to converted value. For example if the temperature gauge is calibrated by giving standard voltage or resistance input, the actual input (e.g. millivolt or milliohms) shall be documented along with the corresponding temperature value.
Actual output displayed or recorded by the test and standard instrument shall be recorded in addition to converted value. For example, when calibrating a thermocouple voltage generated at given temperature is measured using standard multi-meter, then millivolt value shall be recorded along with the corresponding calculated temperature value.
Raw data of Qualification Validation Exercises
Qualification in the pharmaceutical industry basically deals with the facility, equipment’s, systems and utilities. Qualification exercise may include the measurements of velocity/flow rate, pressure, vacuum, temperature, RH, nonviable particulate matters, pH, conductivity/resistivity, TOG, Filter integrity, air dryness etc. by using calibrated test instruments either inbuilt in the system/equipment or suitable external device.
The readings/values as displayed on the test instrument shall be recorded in the prescribed format as per applicable SOP. Where printing capability is available, printouts of the raw data shall be retained after review and sign by the designated personnel.
Validation of process, cleaning, analytical methods etc. requires the documented evidence of data measurement as written in the raw data in Manufacturing/packaging operations and Quality control laboratory.
Printouts of the raw data shall be retained and be attached to the protocol after review/approval by the designated personnel.
Back-up of Electronic data
Electronic data generation and storage is done by many instruments attached to computer systems. Wherever raw data is stored in electronic form, appropriate backup of the data shall be retained.
Back up of the electronic data storage shall be done as per the applicable electronic data back-up SOP.
The electronic back up may be done using server or suitable external storage media.
Retention of electronic data back-up shall be done as per the respective SOP on, Storage, Retrieval and Destruction of Records.
Whenever there is a change in the software, the earlier software shall be retained to ensure readability and retrieval of the old data generated using the software.
ABBREVIATIONS:
QA: Quality Assurance
LOD: Loss on Drying
RH: Related Humidity
RPM: Revolution per minute
TOC: Total Organic Carbon
TDS: Test Data Sheet
REFERENCES:
- i) 21 CFR Part 210 & 211
- ii) ICH Q7 – Good Manufacturing Practice Guide for API
