What Is RCA?
RCA is the Root Cause Analysis and it is the technique used to find out the main reason for a specific problem.
In RCA we use an investigation & data-driven approach to find out the reason for the problem & provide or find out its solution.
Which Tools Are Used For Root Cause Analysis?
Commonly used tools for root cause analysis or problem-solving:
-5 Whys
-Ishikawa Fishbone Diagram (IFD)
-Failure Mode and Effects Analysis (FMEA)
-Fault Tree Analysis (FTA)
-Pareto Chart
-Scatter Diagram
What Is Line Clearance?
Line clearance is the activity or process which ensures that the area, line, or equipment is free from residues, and labels of previous products and is ready for dispensing,manufacturing,printing or packaging activity.
What We Check During Line Clearance?
During line clearance, QA officers check that all the area and equipment are properly cleaned/washed and there is no leftover of the previous product.
The following main points are checked:
-Area/equipment Identification
-Calibration Record
-Temperature
-Humidity
-Differential Pressure
-Log Books Record
What Is Documentation?
All types of written material used in pharmaceutical industries including procedures, SOPs, work instructions, etc are known as documentation.
What Is Good Documentation Practice (GDP)?
Good documentation practice or GDP is the collection of standards or internationally accepted guidelines that are used for creating documents & record keeping and it helps for data integrity.
What Is ALCOA?
ALCOA is used for good documentation practices and stands for Attributable, Legible, Contemporaneous, Original & Accurate.
What Is SOP?
SOP is the standard operating procedure and it is written instruction about how a task or activity will be performed.
What Is SCP?
SCP is a standard cleaning procedure & is a written document that contains all the instructions regarding the cleaning procedure of equipment, utility, or facility.
What are The Types Of Cleaning?
There are 3 types of cleaning in the pharmaceutical industry:
-Major Cleaning
-Minor Cleaning
-Shift End Cleaning
What Is Change Control?
Change control is a documented system in pharmaceutical industries to control & regulate any changes in the existing system.
Is Change Control Required For New Area Or Equipment?
Most people in the pharmaceutical industry think that change control is only generated when we change any old procedure or equipment but the reality is that it is also generated whenever we want to add any new equipment or facility.
Types Of Changes
Changes May be of two types
-Major Changes
-Minor Changes
What Are Inprocess Checks?
In-process checks are the tests/activities which are performed during the period when a specific activity i.e manufacturing, filling, printing,labeling or packaging.
These checks are performed to ensure that all the required standards are met during a specific operation.
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