Quality Control (QC ) in Pharmaceutical Industry - Guidelines

Quality Control (QC ) in Pharmaceutical Industry - Guidelines : Quality​‍​‌‍​‍‌​‍​‌‍​‍‌ Control (QC) is  the most important aspect of the pharmaceutical industry that keeps the industry in check by ensuring the safety, effectiveness, and consistency of quality of every medicine produced. This process includes testing and evaluating raw materials, intermediates, and finished products in a systematic way to ascertain that the set standards by different regulatory authorities like WHO, USFDA, and CDSCO, among others, are met. In fact, Quality Control extends to every aspect of the medicine made from judging the purity of the active ingredients to the stability as well as microbiological safety of the drug, and thus it is able to guarantee the quality of every batch of the drug to be released into the market. This thorough quality control approach is key to the eradication of contaminants, the maintenance of consistency, and ensuring patient health.

To understand more about the Quality Control (QC ) in Pharmaceutical Industry, here is a blog that contains all the information about each and every important factor that you must know before using the products. 

Understanding the Quality Control in Pharmaceutical Industry

Quality​‍​‌‍​‍‌​‍​‌‍​‍‌ Control (QC) is an integral part of the entire Quality Management System (QMS). It is essentially the organisation, performance, and recording of tests on the constituents of a finished product to demonstrate that the product conforms to the set specifications. QC is not only about finding defects, it is about preventing them by verifying that each production batch satisfies the standards required for release.

Different quality control methods in pharmaceutical fields are mainly based on globally acceptable norms such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ICH guidelines. These guidelines serve as the foundation for the protocols used for analytical testing, documentation, and equipment validation to ensure that the data collected is of high integrity and reliable. A strong quality control program goes beyond simply meeting regulations to include aspects such as brand prestige, fewer product recalls, and an increase in customer loyalty towards pharmaceutical products. In short, QC is not simply a necessary condition imposed by the regulators but rather an integral part of the producers' pledge towards the delivery of safe, quality medicines that contribute to global health ​‍​‌‍​‍‌​‍​‌‍​‍‌improvements.

The main agenda of quality control is to ensure : 

• The product is clean and free of any type of contamination.
• The product complies with the identity, purity, potency, and safety parameters.
• Each batch of the product is of the same quality and performance as the reference ​‍​‌‍​‍‌​‍​‌‍​‍‌batch.

Key Components of Quality Control in Pharma Industry 

Here are some of the important components of the quality control that must be followed : 

Raw Material Testing

Testing of the raw material is one of the initial and most important steps in quality assurance of the products. This includes all the raw materials   including active ingredients, excipients and packaging materials 

In-Process​‍​‌‍​‍‌​‍​‌‍​‍‌ Control

The quality of the samples is checked and ensured to be at their best by checking parameters such as pH, temperatures, viscosity, and tablet hardness to be in the specified limits. Finished Product Testing

The batch of products that are produced are tested for their quality, identity, strength,  purity, dissolution, microbial contamination and appearance. .

Stability Testing

Stability tests are used to define the storage period of a pharmaceutical product. The drugs are exposed to various environmental conditions (temperature, humidity, light) to check their quality over time.

Microbiological Testing

Microbiological analysis is performed to ensure the absence of harmful microorganisms in both sterile and non-sterile products. The procedures included are sterility testing, endotoxin testing, and microbial limit testing.

Documentation and Record-Keeping

Every QC operation must be documented. The records are a proof of the company's adherence to the rules and regulations and also they provide traceability for each batch in case of an investigation .‌​‌ ‌

Regulatory Guidelines for Quality Control

The pharmaceutical industry operates under rigorously applied international and national guidelines in the name of safety to the consumer. Some of the principal QC-related guidelines are:

Good Manufacturing Practices (GMP)

GMP set by WHO and other various national regulating authorities provides the very basics of manufacturing, testing, and quality assurance. The QC laboratories should necessarily operate under GMP to ascertain the trustworthiness and the exactness of the test outcomes.

ICH Guidelines (International Council for Harmonisation)

ICH, in fact, facilitates offering globally a unified technical requirement for the pharmaceutical industry. Among many, some of the ICH guidelines related to QC are:

• ICH Q2(R2): Validation of analytical procedures.
• ICH Q3A/B: Impurity testing for drug substances and products.
• ICH Q6A: Specifications for new drug substances and products.
• ICH Q1A: Stability testing of newly drug substances and products.

Pharmacopeial Standards (IP, BP, USP, EP)

The corresponding QC laboratories will get the role of testing products according to the pharmacopeial methods laid down in the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), or European Pharmacopoeia (EP).

Good Laboratory Practices (GLP)

GLP is a system developed to provide trustworthy and reliable laboratory testing results. It encompasses the qualifications of the staff, the documentation, the calibration of the instrume...

WHO Technical Report Series (TRS)

WHO regularly publishes technical reports and annexes that not only specify but also describe in detail the QC standards and testing to be done in the pharmaceutical품 industry.

Process of quality control 

Process​‍​‌‍​‍‌​‍​‌‍​‍‌ of Pharmaceutical Quality Control

The complete process of pharmaceutical quality control is a very complex task and follows a very complex routine. The complete steps include various key stages such as : 

Sample Collection- Scientifically justified sampling procedures are applied to collect representative samples from each batch.

Testing- Samples are to be analysed strictly following approved specifications by using validated methods.

Review and Approval- The results are being reviewed and authorised by the qualified personnel of the QC department.

Batch Release or Rejection- The Quality Assurance (QA) department, through the evaluation of the QC report decides on the release of the batch for the market or not.

Investigation and CAPA- Local management shall initiate a prompt investigation into the root cause of the failure and implementation of corrective and preventive actions (CAPA) in case the batch fails any test.

Why is Quality Control Critical for a Pharmaceutical Company?

Here are some of the key factors and points that show why quality control is a very critical pharmaceutical company.

Patient Safety- By removing those impurities that may be harmful to the patient, the drug is ensured to be safe.

Product Efficacy- Every time a product is to be used, it shall provide the intended therapeutic effect, and this is what product efficacy is about.

Regulatory Compliance- This means freedom from violations that lead to product recalls, penalties, or suspensions of a license of operation.

Brand Reputation- The consumer’s trust is a big asset for the brand, and through quality, it gets steadily built up.

Cost Efficiency- The early detection of the problem is a good practice that saves the company from wastage and production ​‍​‌‍​‍‌​‍​‌‍​‍‌losses.

Conclusion 

Quality Control (QC ) in Pharmaceutical Industry is the most important part of the pharma industry It protects patients by making sure that each drug made is of the best quality and has the desired effect. Following the QC instructions such as GMP, GLP, and ICH standards is definitely a regulatory necessity, but it is also a manufacturer's moral.

Though there is global competition and the demand for better healthcare keeps rising, the industry cannot afford not to invest in strong QC processes, state-of-the-art analytical instruments, and well-trained staff if it wants to keep its promise: most of the information related to is mentioned in the above blog of Quality Control (QC ) in Pharmaceutical Industry - Guideline.