Quality Control (QC) is the most important area in the Pharmaceutical industry.
Quality Control (QC) in Pharma industry
A major part of quality assurance is Quality Control defined by ISO as “the operational techniques and activities that are used to satisfy quality requirements. “An important part of quality control is the Quality Assessment: the system of activities to verify if the quality control activities are effective, in other words: an evaluation of the products themselves.
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Quality control is primarily aimed at the prevention of errors. Yet, despite all efforts, it remains inevitable that errors are being made. Therefore, the control system should have checks to detect them. When errors or mistakes are suspected or discovered it is essential that the “Five Ws” are trailed:
What are those errors?
Where was it happen?
When was it occur?
Who is the person?
What is the reason?
When the answers are available for all these questions, then only proper action can initiate to correct the error and prevent the same mistake by avoiding repeating errors.
Quality Control (QC) activities
The techniques and activities involved in Quality Control can divide into four levels of operation:
First-line control: Instrument performance check.
Second-line control: Check calibration or standardization.
Third-line control: Batch control (control sample, identity check).
Fourth-line control: Overall check (external checks: reference samples, interlaboratory exchange programs).
Because the first two control levels both apply to the correct functioning of the instruments they are often taken together and then only three levels are distinguished. This designation is used throughout the present Guidelines:
First-line control: Instrument check/calibration.
Second-line control: Batch control
Third-line control: External check
It will be clear that producing quality in the laboratory is a major enterprise requiring continuous human effort and input of money. The rule of first is that 10-20% of the total costs of analysis should be spent on quality control. Therefore, for quality work at least four conditions should be fulfilled:
means are available (adequate personnel and facilities)
efficient use of time and means (costs aspect)
expertise is available (answering questions; aftercare)
upholding and improving the level of output (continuity)
In quality work, management aspects and technical aspects are inherently cobbled together and for clear insight and proper functioning of the laboratory, these aspects have to be broken down into their components. This is done in the ensuing chapters of this manual.
Laboratory Control
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall follow and document at the time of performance. Any deviation … shall record and justify.
(b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.
(c) Samples shall be representative and properly identified
(d) The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program.
(e) Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not use.
Quality Control (QC) Testing and Release for Distribution
(a) “For each drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product.
(b) “The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented [validated].”
(c) Any sampling and testing plans shall be described in written procedures that shall include the method of sampling and the number of units per batch to be tested.
(d) Acceptance criteria with appropriate acceptance levels and/or appropriate rejection levels for the sampling and testing.
Good Laboratory Practices (GLP) at Quality Control (QC)
Quality Management in the present context can be considered a modem version of the hitherto much-used concept of “Good Laboratory Practice” (GLP) with a somewhat wider interpretation. The OECD Document defines GLP as follows: “Good Laboratory Practice (GLP) is concerned with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported.”
Thus, GLP prescribes a laboratory to work according to a system of procedures and protocols. This implies the organization of the activities and the conditions under which these take place are controlled, reported, and filed. GLP is a policy for all aspects of the laboratory which influence the quality of the analytical work. When properly applied, GLP should then:
allow better laboratory management (including quality management)
improve efficiency (thus reducing costs)
minimize errors
allow quality control (including tracking of errors and their cause)
stimulate and motivate all personnel
improve safety
improve communication possibilities, both internally and externally.
The result of GLP is that the performance of a laboratory is improved and its working effectively controlled. An important aspect is also that the standards of quality are documented and can be demonstrated to authorities and clients. This results in an improved reputation for the laboratory (and for the institute as a whole). In short, the message is:
say what you do
do what you say
do it better
be able to show what you have done
GLP basic rules
The basic rule is that all relevant plans, activities, conditions, and situations are recorded and that these records are safely filed and can be produced or retrieved when necessary. These aspects differ strongly in character and need to attend to individually.
As an assembly, the involved documents constitute a so-called Quality Manual. This comprises then all relevant information on:
Organization and Personnel
Facilities
Equipment and Working materials
Analytical or testing systems
Quality control
Reporting and filing of results.
Since institutions having a laboratory are of divergent natures, there is no standard format and each has to make its own Quality Manual. The present Guidelines contain examples of forms, protocols, procedures, and artificial situations. They need at least to be adapted and many new ones will have to be made according to the specific needs, but all have to fulfill the basic requirement of usefulness and verifiability.
Laboratory Premises
Maintain laboratory and its premises clean.
Clean and disinfect the sterile and microbiological testing area.
Maintain all equipment/instruments clean and to the extent possible covered.
Maintain all analytical balances on a steady platform, away from air current and vibration.
Measure the temperature of the laboratory at least twice a day.
Keep the workbench of laboratories clean and tidy at all times.
Ensure only the current versions of all master documents are available in the laboratory.
Ensure all equipment/instruments are qualified as per relevant protocols before putting them into use.
Allot identification numbers to all analytical instruments/equipment.
Maintain all instruments/equipment in calibrated status.
Identify “Under Maintenance” instrument/equipment and prevent usage of same.
SOPs and logbooks must maintain at the workplace where they can easily access them.
Ensure all liquid/ gas chromatography columns have numbers as per the procedure.
QC Personnel
Always wear the company uniform or apron as applicable on the laboratory premises.
Do not drink and eat in the lab.
Follow the entry exit procedure wherever applicable.
Follow safety instructions carefully all the time.
Wear safety apparel and equipment as applicable on the laboratory premises.
Quality Control (QC) Practices
Analysts shall perform an analysis of samples after they are qualified and certified as per the procedure.
Update the daily analytical work plan and status on the relevant documents.
Enter all analytical records concurrently during the analysis.
Ensure all the laboratory documents are securely placed in a polythene folder and kept at the designated place.
All analytical work shall be carried out by referring to approved current documents such as SOPs, GTPs
Protect all documents from spillage of chemicals and solutions when performing analysis.
Circle the desired option, when multiple options are provided unless specified otherwise.
Use only class “A” category volumetric glassware (Pipettes, burettes, and volumetric flasks).
Store all cleaned and dried glassware in dust free storage area.
Use clean and dry glassware for analysis.
Check glassware for any cracks or dirt before using them.
Glassware meant for residual solvent analysis, shall dry at a higher temperature to avoid any trace contamination.
To the extent possible rinse the glassware with solvent or diluent which is meant for analysis in case of critical test procedures such as related substances.
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