Significance Of Quality Control In Pharmaceutical Manufacturing

By Author: Rashmi
Total Articles: 5
Comment this article

One of the most crucial facets of any product is its “quality “. The significance of the product depends heavily on its quality as higher the quality, higher the trust and sales or vice versa. It is extremely difficult to find the people who are ready to compromise the quality of a product.

Therefore, quality is the key ingredient for the success of any organization.

When we talk about the process manufacturing industry primarily the pharmaceutical manufacturing, the significance of the quality goes many steps above. Quality is like non-negotiable for one of the highest regulated sectors in the world.

Products that are manufactured in manufacturing industries go through the various levels of scrutiny as the slight deviation in the product can lead to death. Therefore, pharma manufacturers check the product quality at every level of manufacturing and produce the final products that meets the stringent regulatory standards. Nonetheless, pharma manufacturers require a tool that helps them to develop quality products.

Modern day pharmaceutical ERP software include a QC (Quality control) functionality ...
... in their systems so that the manufacturers get the products that meet the requisite standards and quality requirements. QC in ERP allows pharma manufacturers to maintain the quality and standards of their products thus making their life quite less stressful and helps them in making better decisions.

The Quality Control System for ERP software for pharmaceutical industry enables manufacturers to develop products that are safe, effective and pure. The evaluation of safety & maintenance of products majorly depends on how quality is controlled in pharmaceutical manufacturing.

Quality is controlled at every stage of manufacturing, mainly at the time of:

1. Receiving Raw Materials:

The raw material for pharmaceuticals is only bought through FDA- approved and verified suppliers. As per the SOP (standard of procedure) any kind of raw material that is used for the pharmaceutical manufacturing process is placed in an isolated (quarantine) area. Inspection plans and checklists are used to identify which material is fit to use and which one needs to be rejected. The raw materials that are acknowledged for further processing only after passing all the quality standard tests.

2. During Manufacturing Process:

Once accepted, the next process is of moving raw material towards manufacturing sectors. According to cGMP, each process must be properly documented so that it can be executed within pre-defined quality parameters. Each manufacturing unit is available with few documents that helps them to maintain quality standards.

The two documents that are widely used in pharmaceutical manufacturing are Master Batch Record and Batch Manufacturing Record. MBR consists of several instructions that contain all the relevant data including input material lists, valid SOPs and detailed work instructions that are to be applied in production.

BMR document that consists of step by step instructions for manufacturing each batch like when, how, by whom, with what tools and in which environment the product is supposed to be produced. It also carries data such as batch records, BOM, equipment cleaning record etc.

3. After Manufacturing:

Post manufacturing process, samples are taken, and tests are conducted on the products to ensure the quality and specification standards. All the distributors and distributed products are tracked virtually so that the offending products can be withdrawn easily.

About Probiz ERP:
Probiz is an enterprise resource planning software that is specially designed to simplify all the business operations and deliver value faster than ever. Probiz; an ultimate pharma ERP solution that covers all the aspects of business management and manufacturing which let you expand in your market through enhanced collaboration, higher sales and better compliances with stringent mandates.
For more information, please visit www.probizerp.com