Electronic Document Management System [EDMS]

Like procedures, protocols, methods, and specifications, documents provide instructions to perform tasks and make decisions safely, effectively, compliantly, and consistently. Records such as batch manufacturing records, cleaning logs and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were made in keeping with procedures and GMP expectations. Reports are yet another type of documentation that provide specific information on investigation and aspects of product development in a formal, standardized way. Reports may include data summaries, findings, actions to be taken etc. Each document, records, and reports must be uniquely identified and included all GMP requirements.

Data Integrity (Part-III) (Some Major Observations)

Observation 1

Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards

The firm inspected lacked accurate raw laboratory data records for batches of API that were shipped. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, Quality Control (QC) laboratory failed to include complete data on QC testing sheets. Failing or otherwise atypical results were not included in the official laboratory control records, not reported, and not investigated.

Data Integrity Part-II (Laboratory)

Most companies have experienced being audited and, where necessary, “defending” the work carried out in their analytical laboratories during audits. Historically, laboratories have tended to provide information about the validation of their methods and procedures, the qualification and suitability of their analytical equipment, and information about training of their laboratory staff as justification for the validity of the analytical results.

Data Integrity -Part-I

The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records.

Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future. Regulatory inspectors, during their inspections of manufacturing sites, often spend much time examining a company’s documents and records.

Data may be generated by

(i)                a paper-based record of a manual observation, or

(ii)              in terms of equipment, a spectrum of simple machines through to complex highly configurable computerized systems. The inherent risks to data integrity may differ depending upon the degree to which data (or the system generating or using the data) can be configured, and therefore potentially manipulated

Systems should be designed in a way that encourages compliance with the principles of data integrity.