Quality Control Documents, in short, QC Documents are essential requirements in order to maintain compliance at the QC department. Quality documents are categorized into different forms based on the requirements. Refer below to the short names, full form, definitions of the types of QC Documents, and details.
List of Quality Control Documents
SOP: Standard Operating Procedure
STP: Standard Testing Procedure
COA: Certificate of Analysis
ATR: Analytical Test Request
ROA: Record of Analysis (Work Book/ Raw-data book)
IC: Internal Communication
Release Specification: Specification which shall comply with the release.
Customer Specification: Specification which shall comply to meet the Customer requirements.
Shelf Life Specification: Specification which shall comply entire shelf life duration for Drug Substances and Drug Products.
SOP – SOP contains Standard Operating Practices which are required to perform a particular operation.
STP – Standard Test Practices contains standard testing practices to follow during the analysis of a particular product.
Specification – Specification is a list of tests along with predetermined limits against which the quality of the product needs to analyze.
Refer never before to Pharma articles only at PharmaeliX. OOS SOP Preparation of Solutions Method Transfer Guidance for Pharma Industry ICH Safety Guidelines Electrogravimetry Basic Guidance Microbiology Basic Principles
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