ALCOA is a cornerstone principle of Good Documentation Practice (GDP). It applies to both paper and electronic documents. ALCOA was first introduced by the FDA’s Associate Director Stan Woolen in the 1990s as a straightforward and practical guide. But over the years, it has become the gold standard for data integrity and compliance with the CGMP. (Data integrity refers to the completeness, consistency, and accuracy of data.) ALCOA aims to help organizations achieve their key objectives of data integrity. The acronym is derived from the terms attributable, legible, contemporaneously recorded, original, and accurate:
Attributable
The first and most important element is identifying the source of any data. It is imperative to know the product and process of the data generation and the circumstances under which data was generated. Therefore, all data should include details such as:
-
-
- Product name
- Process name
- Who performed the process and collected the data
- Who verified the above
- Who corrected the data
- Batch name and size
- Lot name and size
- Relevant calculations
- Input material names and weights
- Labeling and packaging material
- Sample names and locations
- Manufacturing location and equipment
- Instrument for sample analysis
- Who performed the analysis
-
The Code of Federal Regulations (CFR) that relate to this are 21 CFR 211.101(d), 21 CFR 211.122, 21 CFR 211.186, 21 CFR 211.188(b)(11), and 21 CFR 212.50(c)(10).
Legible
Data is of no use if it does not exist in an easy-to-read format. Therefore, all manufacturing records, complaints, recalls, returned or salvaged products, and deviations should be kept in legible form. That means handwritten paper documents need to be in legible condition, and electronic records need to be recorded and stored on long-lasting materials of good quality, that are also available for review and copying by FDA employees. The connected CFR are 21 CFR 211.180(e) and 21 CFR 212.110(b).
Contemporaneously Recorded
Creating records with back-dated information does not fit with the data integrity principle. Therefore, data should be recorded at the time of performance itself. This means every manufacturing record should be accompanied with the corresponding date and time when it was recorded. It is especially critical in cases where the sample is to be withdrawn at specified time intervals or in cases where process parameters change with time. Furthermore, the principle of contemporaneous recording applies not only to original data but also to corrections in the data. Hence, any data corrections should also be accompanied by the corresponding date, time, and signature of the person who made the correction. The CFR relating to this are 21 CFR 211.100(b) and 21 CFR 211.160(a).
Original
In the context of data integrity, original means that the true copies of the production, quality control, or distribution records should be preserved for FDA review. The original records need to be retained as per the FDA’s Record Retention Policy. The record retention period varies according to the type of product and expiration date for the product. Therefore, to comply with this requirement, manufacturers need to make provisions for prolonged storage of the true copies of the data. The provisions in the CFR which pertain to this are 21 CFR 211.180 and 21 CFR 211.194(a).
Accurate
Accurate means that the manufacturing data should be error-free. If the recorded data satisfies all the above conditions but is inaccurate, then all data is invalid. Therefore, any changes or amendments in the data should be accompanied by supporting documents. Suppose automatic, mechanical, or electrical equipment or computers are used for recording the data: In that case, such equipment should be routinely calibrated, inspected, and checked according to a written procedure. Only authorized persons should have full access to make changes in the master production and control records. The CFR that relate to the term “accurate” are 21 CFR 211.22(a), 21 CFR 211.68, 21 CFR 211.188, and 21 CFR 212.60(g).
ALCOA+
In the 2010s, four more terms were added to ALCOA to update the concept, and ALCOA+ was born. The terms, Complete, Consistent, Enduring, and Available were added to serve as a framework for handling data in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
