🎀 Role of Quality Assurance in Pharmaceutical Industry 🎀

🔸Quality assurance also known as Q.A is a very important department in pharmaceutical industries and as the name indicates this department assures the quality of the products.

🔸Quality assurance is a broader term and this department is involved in a large number of activities in pharmaceutical industries, some are given as below:

1.Documentation

2.Line Clearance

3.Dispensing Activity

4.In-process Control

5.Sampling

6.Release Of Batches

7.Training

8.Audits

1️⃣ Documentation

🔸Documentation is very important in pharmaceutical industries and different types of documents are prepared and reviewed by the Quality assurance department.

👉🏻Documentation may include :

🔹Corrective and preventive action (CAPA)

🔹Standard operating procedures (SOPs)

🔹Standard cleaning procedures(SCPs) 

🔹Change Controls etc

2️⃣ Line Clearance

🔸Line clearance is the process that is carried out before starting any activity in the pharmaceutical industry.

🔸Line clearance activity is performed to assure that the area or line is free from the leftovers of the previous batch.

🔸After awarding line clearance by the production pharmacist it is cross-checked by the Quality assurance Q.A  pharmacist.

🔸No activity of manufacturing, packaging etc is started until and unless not verified by the Q.A inspector.

3️⃣ Dispensing Activity

🔸Dispensing is the critical process that is carried out in the pharmaceutical industry under the supervision of a Q.A officer.

🔸Dispensing of raw material is done according to the dispensing order to start the manufacturing process in the pharmaceutical industry.

🔸Dispensing of packaging material is also supervised by the Q.A inspector.

🔸All the process of dispensing is carried out under the supervision of a Q.A officer to ensure that all the ingredients are weigh according to the dispensing order.

4️⃣ In-process Control

🔸In-process control means the control of process during its manufacturing to ensure that product is manufactured according to the desired standards and quality of products meets all the required standards.

🔸Different types of in-process tests are performed for different dosage forms:

👉🏻For syrup filling following process tests can be performed:

🔹Area Differential Pressure, Temperature, RH

🔹Optical Verification

🔹Volume Variations 

🔹Sealing

👉🏻For Tablet Compression following process tests can be performed:

🔹Area Differential Pressure, Temperature, RH

🔹Weight Variations 

🔹Friability 

🔹Disintegration 

🔹Hardness

🔹Thickness 

🔹Shape and Diameter 

👉🏻For Blistering following process tests can be performed:

🔹Area Differential Pressure, Temperature, RH

🔹Leak Test

🔹Embossing Information include Batch No, MFG, EXP, Price Etc

🔹Heating and Sealing Temperatures 

🔹Foil Alignment 

👉🏻For Sachet Filling following process tests can be performed:

🔹Area Differential Pressure, Temperature, RH

🔹Weight variation 

🔹Packaging Foil

🔹Printing or Embossing Information include Batch No, MFG, EXP, Price Etc

🔹Leak Test

🔹Heating and Sealing Temperatures 

🔹Foil Alignment 

👉🏻For Ampoule & Vial Filling following process tests can be performed:

🔹Area Differential Pressure, Temperature, RH

🔹Optical Verification

🔹Volume Variations 

🔹Sealing 

🔹Area Monitoring or Particle Count 

👉🏻For Capsule Filling following process tests can be performed:

🔹Area Differential Pressure, Temperature, RH

🔹Weight Variations 

🔹Locking of Capsule 

🔹Polishing of Capsules

🔹Disintegration If Applicable 

🔸These tests during online operations assure that all the Dosage forms are checked according to the required Standards and are free from any particulate matter and safe for storage and Intake.

5️⃣ Sampling

🔸Sampling is the term used for the submission of different samples from the production department to the quality control department for testing.

For example, if we take the example of tablet manufacturing the sampling is done at different stages like after granulation the sample of the blend is submitted to the Quality control department for  analysis and in the same way, samples are submitted after tablet compression and coating.

🔸All the sampling activities are done by the quality assurance inspector to ensure random sampling for better result assessment.

6️⃣ Release Of Batches

🔸When a product is packed,it is held in quarantine for its release status from the quality control department.

🔸The Q. A is the department that gives final approval for its release from quarantine to the finished goods store after reviewing all the required documents and COAs.

7️⃣ & 8️⃣ Training & Audits

🔸The quality assurance department is also involved in conducting different trainings of the staff and is also involved in house audits of different departments.