Functions of Quality Control in the Pharmaceutical Industry
Introduction:
Quality Control is a critical part of a pharmaceutical company. It is a testing laboratory in the pharmaceutical industry. It performs not only the testing of material but also forces all departments to follow quality standards. QC also furnishes documents like COA, calibration of instruments, stability records, and standardization of volumetric solutions. Quality control ensures the safety of patients by ensuring the right product to send to the market. It is also responsible for the reputation of the company. In this article, we will elaborate on the comprehensive role of quality control in the pharmaceutical industry.
The Role of Quality Control in Pharmaceuticals
The role of quality control in the Pharmaceutical industry is not limited to performing the analysis of raw materials and finished products. It has three broad areas of action include, Ensuring Drug Safety and Efficacy, Compliance with Regulatory Standards, Supervision of analysis, Calibration program, Validation program, and Protecting Public Health. The Quality control department functions far ahead of the above-mentioned roles.Ensuring Drug Safety and Efficacy:
The quality control department is fully responsible for the quality of products. It ensures the quality of products that are intended to consume by patients. The quality control department tests the product at various stages of its manufacturing and produces the certificate of analysis before releasing it for sale in the market. QC department holds the product's release if the product does not pass the quality parameters.
Compliance with Regulatory Standards:
Quality Control department enables the company to comply the regulatory standards like GMP, WHO, USFDA, and UK-MHRA. It plays a vital role to pass any regulatory audit.
Protecting Public Health:
The quality control department protects public health by ensuring the quality of products. It is the only QC department that can stop the release of a sub-standard quality product.
Supervision of analysis:
Quality control has to supervise all analysis processes and in-process functions. The following parameters are to be followed during the supervision of the analysis:- Spot check once a week all registers, reagents, and reference standard solutions
- Frequently observe the actual testing done by the chemist staff.
- Review analytical reports and before singing check and confirm for :
- Completeness of all entries.
- Whether analysis has been done, and confirm that it has been performed as per the specified pharmacopeia or in-house specifications (if specified).
- If not found to comply, the section head should bring to the attention of the QC in-charge / senior QC personnel so that necessary action to rectify/modify the procedure can be taken.
Calibration program:
A calibration program is very essential for any laboratory to ensure that the results found are in a prescribed range of instruments and are not calibrated periodically the whole analysis may go out of acceptance criteria.To ensure there written SOP for calibration of all equipment and instruments which should contain the following information.
i) Maintain a step-by-step sequential procedure for calibration.
ii) Acceptance criteria.
Maintaining a written schedule for the calibration of all equipment and instruments.
To calibrate the equipment and instruments according to the scheduled program and follow the respective SOP during calibration.
Record and store the calibration results in the respective format provided in the SOP.
The quality control department performs the calibration of all instruments in the laboratory including HPLC, UV-Visible, Karl Fischer, Disintegration Test Apparatus, and FTIR, etc.
Validation program for Instruments and testing methods:
The quality control department runs several validation programs for validation of instruments, and validation of test methods. It is a critical part function of the quality control department among many others.
Key Components of Pharmaceutical Quality Control
Raw Material Testing and Verification:
Raw material testing is one of the most significant tasks among the other many important responsibilities. The QC department test all incoming raw materials.
In-Process Quality Checks:
Quality control performs in-process checks during the manufacturing of products. Usually, every production section in the pharmaceutical section has a dedicated IPQC room, where QC personnel perform the basic tests in this area such as weight variation, disintegration test, hardness tests, volume check in liquid, etc.
Final Product Inspection:
After ensuring the quality of the product during the in-process testing, the QC department performs the complete analysis of the product according to the pharmacopeia. They check all parameters given in pharmacopeia for the subjected product, if the product passes all tests then a COA of the product is issued for the final release.
Stability Testing:
QC departments perform stability studies for all products. Stability studies refer to manufactured products whose quality check-ups are done to track the product’s efficacy and other changes in its behaviors.
Purpose of stability testing :
2 To generate data for revising shelf life (extension or reduction of shelf life).
3 To assign shelf life for new drug products.
STUDY STORAGE CONDITIONS:
Long TermTemp. 250C + 20C and RH 60% + 5%
or
Temp. 300C + 20C and RH 65% + 5%AcceleratedTemp. 400C + 20C and RH 75% + 5%
Analytical Techniques in Pharmaceutical Quality Control
In a pharmaceutical company, the Quality control laboratory uses several types of analytical techniques based on a principle or evaluation basis. Some of them are elaborated here:
High-Performance Liquid Chromatography (HPLC):
High-Performance Liquid Chromatography (HPLC) is a technique of separation of molecules passing through a column that is filled with a specific type of material that is able to absorb a particular type of compound. In this technique, a compound can be analyzed both qualitative and quantitative manners. A liquid (Acetonitrile, Acetone, Methanol, and water) is used as a mobile phase, and the stationary phase remains the material packed in the column. The most popular brand in HPLC are Agilent, Shimadzu, and Waters.
Gas Chromatography (GC):
Gas Chromatography (GC) is a technique almost similar to HPLC, the basic difference between these two techniques is the nature of the mobile phase that is gas in GC. Usually, it is used to separate and identify volatile organic compounds. This technology is used to identify and quantify the compounds.
Mass Spectrometry (MS):
Mass Spectrometry (MS) is a technique that is used to identify and measure the mass of a molecule. It is used in pharmaceutical quality control, forensic labs, and drug discovery.
Fourier Transform Infrared Spectroscopy (FTIR):
Fourier Transform Infrared Spectroscopy (FTIR) is a commonly used technique in the pharmaceutical industry for quality assurance/quality control (QA/QC) of pharmaceutical substances and material identification. It is a fast and nondestructive analytical method. FTIR spectroscopy is often used for analyzing solid, liquid, and biotechnological pharmaceutical forms.UV-Visible Spectrophotometry:
UV-visible spectrophotometry is a technique that uses the absorption of ultraviolet (UV) and visible light by molecules to identify and quantify them. In this technique, you can Identification of APIs, Quantify impurities, Analysis of finished pharmaceutical products, Study drug stability, and Development of new drugs. It is a non-destructive technique where you can reuse that sample again.Microbiological Testing in Pharmaceutical Quality Control:
In quality control, Microbiological tests are also done as a type of analysis. There are several types of tests that are necessary to complete a test in a microbiological laboratory. Common tests that are performed in microbiology lab are listed below:
- Sterility Testing
- Endotoxin Testing
- Assay by microbiology method
- Bioburden Testing
- Environmental Monitoring for Cleanrooms
Quality Control Documentation and Record-Keeping
Standard Operating Procedures (SOPs):
Quality control is responsible for the preparation of all SOPs applicable in the quality control department under the guidance of the Quality Assurance department. It has to prepare SOPs for all instruments, Testing methods, preparation and standardization of solutions, preparation of documents, and quality checks.
Certificate of Analysis and Batch Release:
The QC department analyzes and prepares the test report (COA) for all materials and finished products in the company. The product is released for sale in the market after the issuance of a Batch Release certificate by the quality control department.
Laboratory Notebooks and in-process records:
They have to prepare a complete record of logbooks for each step in the analysis, instrument usage, and calibration of instruments. It is very important to maintain the day-to-day record of all machines' log books, and STPs (Standard Testing Procedures) that can justify the COA issued for a product or raw material. At the time of audits, these documents are duly verified by auditing authorities.
Electronic Data Integrity:
The pharmaceutical industry has been evolved according to time. Now electronic data integrity is becoming very essential to meet regulatory compliances. The term ALCOA+ is very popular in the pharma industry to integrate the data and comply with tough certification bodies like US-FDA, TGA, MHRA, etc. The whole data integration is the responsibility of the quality control department.
Retention of Records
The period up to which laboratory records are to be retained by the manufacturer is stipulated in the Drugs and Cosmetics Act, Rules 1945.
Quality Audits and Inspections
The quality control section is a core part of any Internal or Regulatory inspection. They have to produce all documents related to analysis, and processes that took place in the company ensuring a compliance manner.
Internal Audits:
Every pharmaceutical company organizes an internal inspection after a period of 3 months or 6 months. It is also known as the self-inspection, where all key personnel from QA, QC, Production, and management are involved in the inspection. They observe shortcomings and rectify them timely to avoid any quality issues.
External Audits from Regulatory Agencies:
The quality control department takes care of all external audits and regulatory agencies' inspections. However, all departments QA and production are involved equally in any audit but the maximum load of documentation remains on the Quality control.
Corrective and Preventive Actions (CAPA):
Corrective and Preventive Action (CAPA) is a process that addresses a situation where a quality issue is generated due to an error in the process. A CAPA is initiated by the QA and management to rectify the error, the role of Quality Control remains very important in the whole process(CAPA).
Quality Control in Good Manufacturing Practices (GMP)
GMP Requirements for Pharmaceuticals:
"Good Manufacturing Practices" is an essential quality mark that is necessary for all companies to comply. Quality Control has a wide role in the whole process of achieving and following GMP in the company. QC is responsible for ensuring the quality of products before sending them to the market for human consumption. Roles of Quality control in the GMP process are:
- QC's job is to conduct tests of raw materials, packing materials, products in-process, and finished goods final tests to comply with the GMP standards.
- Monitoring the whole manufacturing process.
- Investigating and rectification of quality issues.
- Maintaining the records complying with GMP norms.
GMP Training and Compliance:
Quality Control and Continuous Improvement
Lean Six Sigma Principles in Pharmaceutical QC:
Lean Six Sigma is a methodology that consists of two separate approaches to process improvement: Lean and Six Sigma. It is used to improve quality and efficiency in pharma manufacturing and service industries. In the pharmaceutical industry, Lean Six Sigma principles are applied to improve operational efficiency and quality while facilitating compliance with complying regulatory norms. This technology fulfills the requirements of Good Manufacturing Practice (cGMP). It is a cost-effective and time-saving process.Total Quality Management (TQM) in the Pharmaceutical Industry:
Total Quality Management (TOQ) is a theory of management that is based on the belief in improving the quality of products. This practice is to match the exceeding expectations of customers about product quality. The pharmaceutical industry is a highly regulated industry that requires an extreme level of alertness toward the quality of products. TQM is a quality framework where all members of the organization can contribute to long-term success. Each member from top to bottom focus on the quality of products and try to improve it continuously.
Summary:
Quality Control (QC) in the Pharmaceutical Industry is the department that performs the actual testing on raw materials, as well as final products, Packing materials, and Water testing. They execute the analysis of chemical batches or Calibration of Equipment, testing of samples, and compiling the performance data. Quality Control plays an important role in any FDA inspection. The quality Control department has to prepare maximum processing data, like Analysis reports, Calibration records, Retention of samples records, Validation of process, and Validation of Instruments records. QC should be powerful in any pharmaceutical company.
References:
- Pharmaceutical Analysis using FTIR: Compliance with European, US, Indian, and Japanese Pharmacopoeia [Agilent(.com)]
- Quality control guidelines [World Health Organization]
- Schedule-M, Part-I: Quality Control System [Drug and Cosmetics Act, 21st edition -By Vijay Malik, PP-453]
- Corrective and Preventive Actions (CAPA) [FDA(.gov)]
- A Review of Total Quality Management in the Pharmaceutical Industries-Parul University, Vadodara, Gujrat, India [IJCRT.org]
- Health products policy and standards-Good Manufacturing Practices [World Health Organization]
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