Basic Concept of Pharma-2

Commissioning: Ensures that utilities, manufacturing facilities and equipment is designed properly and functions as intended as defined in the URS.

Deviation: Deviation is any change from written procedure like Protocols, SOP, STP, BMR. Etc. Any deviation from established procedures should be documented and explained. Critical deviations should be investigated and the investigation and its conclusion should be documented.

Incident: It’s an unwritten event that is against GMP. Incident can be defined as unplanned or uncontrolled event in the form of non-compliance from the designed systems or procedures

at any stage of manufacturing, packing, testing, holding and storage of drug product due to system.

Out of Specifications (OOS): Results generated during testing that do not comply with relevant standard or specification.

Out of Trends (OOT): Any test result obtained for a particular batch that is markedly different from the results of batches in a series.

Change Control: A Process which ensures that changes to procedures, materials, methods, equipment, and software are properly documented, approved, validated and traceable.

Corrective Action and Preventive Action (CAPA): CAPA consists of improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.

Corrective Action: Action required to correct and prevent a re-occurrence for something that happened yesterday

Preventive Action: Action required to prevent an occurrence of something that may happen tomorrow

Root Cause Analysis: Root cause analysis is a problem solving technique for identifying the basic or cause factor (s) that underlie the occurrence or possible occurrences of an adverse event in a process similar to diagnosis of disease – with the goal always in mind of preventing reoccurrence.

Risk Assessment: A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

User Requirements Specifications (URS): URS describes what users require from the system. URS are written early in the validation process, typically before the system is created

URS will be written by the system owner and End users, with input from Quality Assurance

Validation Plan: Validation Plan define the scope and goals of a validation project. These are specific to a single validation project. VP include deliverables to be generated during the validation process and Validation Team and the time line for completing the project.

Design Qualification (DQ): Documented verification that the proposed design of facilities, systems, and equipment is suitable for the intended purpose.

Functional Specifications (FS): The functional specifications document, if created, define functions and technological solutions that are specified for the computerized system based upon technical requirements needed to satisfy user requirements.

Functional Risk Assessment (FRA): A functional risk assessment is performed following approval of the functional specification to identify potential risks. Mitigation activities are then planned to manage the identified risks and allow focusing on critical areas, e.g.by modifying functionality, detailed testing, procedural controls or training.

Installation Qualification (IQ): Establishing a high degree of confidence that the equipment as installed is consistent with manufacture’s requirements and specifications.

Operating Qualification (OQ): Establishing a high degree of confidence that the equipment as installed is able to consistently operate within established limits and tolerances.

Performance Qualification (PQ): Establishing a high degree of confidence, with appropriate testing that the equipment, under normal operating conditions, will consistently produce a quality product.