Quality Agreement – A Quality Agreement is a binding document, in addition to any standard service contract or agreement, that identifies all the quality control, quality assurance, and related regulatory responsibilities and obligations of a vendor and customer to one another in order to conduct business in full compliance with the applicable Good Manufacturing Practices (GMP’s).
Formulation Data Sheet – A Formulation Data Sheet or FDS is a controlled document that identifies all of the parameters and acceptance criteria for a given formulation, as defined by the owner of a given formulation such that the product can be produced reliably and be upheld to the standards of production. This document is not the same as a Specification Sheet for the given formulation.
Ingredient Data Sheet – An Ingredient Data Sheet or IDS is a controlled document that identifies all the parameters and acceptance criteria for a given ingredient, including all ingredient sources, as defined by the owner of a given formulation to which the ingredient may be included, such that the end product can be produced reliably and be upheld to the standards of production. This document is not the same as Certificate of Analysis or Specification Sheet for the given ingredient.
Specification Sheet – The Specification Sheet or “Spec Sheet” is a controlled document that identifies the parameters, testing methodology and other criteria for a given formulation or ingredient, as defined by the vendor accepting the raw material(s), manufacturing the raw material(s), manufacturing the finished product(s) inclusive of co-packing, or conducting the release testing of the ingredient(s) or finished product(s).
Quality Manual – A Quality Manual is the governing set of Standard Operating Procedures, inclusive of the Master SOP, that all companies operating in compliance with the applicable GMP’s based on their business type, must maintain current at all times, whether electronically or a in paper-based format.
Standard Operating Procedure – The Standard Operating Procedure (SOP) is the fundamental document required to define each daily activity, role and responsibility of key personnel and operational function involved in the production, testing, storage, transportation and/or distribution of raw materials and/or finished products.
Quality System – The Quality System or “Quality Program” is the general term to addresses all aspects of given company’s quality control, quality assurance and regulatory affairs activities, including the Quality Manual, SOP’s and all applicable controlled documents. Quality System’s are unique to a company’s business model, target market(s) and geographical location(s).