Good Documentation Practices And Data Integrity. Quality Assurance.
GDocP-DI. Good Documentation Practices Good documentation practice (commonly abbreviated as GDP recommended to abbreviate as GDocP to distinguish from "good distribution practice") is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. ALCOA + ALCOA+ is a set of principles that ensures data integrity in the life sciences sector. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration. It has relevance in a range of areas, particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain..
[image] Legible recorded. What is ALCOA+ ?. Term Description/Explanation A Attributable Data is attributable to the person or system generating the data L Legible Data is legible, permanent, traceable, readable and understandable throughout the entire life cycle of the record. C Contemporaneous Data is recorded at the time it’s generated or observed O Original Original record or Certified copy. First or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GxP activity A Accurate Data is correct, truthful, complete, valid and reliable for both paper and electronic records. Data should be reliable..
What is ALCOA+ ?. Term Description/Explanation + Complete All relevant raw data and metadata must be collected, including retests or reanalysis. Consistent Information should be created, processed, and stored in a logical manner that has a defined consistency. This includes policies or procedures that help control or standardize data (e.g. chronological sequencing, date formats, units of measurement, approaches to rounding, significant digits, etc.). Enduring Records should be kept in a manner such that they exist for the entire period during which they might be needed. This means they need to remain intact and accessible as an indelible/durable record throughout the record retention period. Available Can be accessed for review & audit or inspection over the lifetime of record..
Document: Document is guideline for activities. A document is written, drawn, presented approved instruction either in paper or electronic form which guides about how an activity shall be executed. Documents can be stored as paper or digitally. It can be changed and revised as needed. Documents are required for one or more of the following reasons: Keep track of activities Create legal documents Provide a historical record Provide information Comply with regulations.
Characteristics of Document: Accurate General Principle of Documentations Authentic Clear Complete Current Version Legible Permanent.
Batch Record Forms Bills of Materials (BOMs) Specifications Policies Protocols Standard Operating Procedures (SOPs) Work Instructions (WIs) Test Methods Forms/log sheets/checklists Training assessments Electronic and hardcopy Quality records Certificate of Analyses (CoA) or Certificate of Compliance (CoC) Technical transfer reports. Validation documentation.
Documentation: Documentation is a set of documents that provides Official information or evidence or that serves as a record. Controlled documents: The document that have limited and specific distributions and are marked with red stamped phrase "CONTROLLED COPY" are termed as controlled documents. It is the distribution that is being controlled. Examples of controlled documents are Standard Operating Procedures, Formats, Annexure etc. Data: Data is a set of values of qualitative or quantitative variables. Facts and statistics collected together for reference or analysis..
[image]. The ALCOA principles that ensure data integrity apply to the following types of GMP records: Electronically recorded – data recorded using equipment from simple machines through to complex and highly configurable computerized systems Paper-based – a manual recording on paper of an observation or activity Hybrid – where both paper-based and electronic records constitute the original record Other – this includes photography, images, chromatography plates, and more.
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