Welcome to The Pharmaceutical Page

Chemical Manufacturing

Pharmaceutical Manufacturing involves the manufacture of APIs into a product in a GMP environment.  Pharmaceutical manufacturing can involve complex systems which require regular in-process analysis, inspection, testing, document control, data collection, and may require quality investigations. 

 

Maintaining and documenting detailed and accurate policies, procedures, results, and work instructions, according to specified regulations, is important in maintaining a process that is compliant, and meets customer requirements. The batch review process is essential to ensure the quality of your product and in meeting customer and regulatory requirements.  Incorrect records or processes can lead to out-of-spec products and nonconformances during the audit process.

 

Quality As You See It has the experience and knowledge in pharmaceutical manufacturing to support your in-process activities, document control, batch recorded review, and quality investigations. 

Batch Record Review

Batch Record Review is an important part of in-process validation. Manufacturing Processes must be carefully followed and documented. If processes are not followed and/or documented incorrectly, the product can suffer many issues that could result in high-cost, recalls and/or sending an ineffective or unsafe product to market. Quality As you See it has experience in the collection, and analysis of data, and investigating issues that may occur during the Batch Record Review process. 

Document Control

To eliminate errors during the production process, and adhere to regulation and customer requirements, organizations are forced to implement stringent document control processes.  Quality As You See It can support your organization in performing audits to ensure accuracy of all controlled documentation, assisting in change notification processes, and in recommending, creating, implementing, and controlling new and existing procedures. 

In-Process Validation

In-process validation is an essential process in the pharmaceutical industry. The collection and analysis of data throughout the manufacturing process produces evidence your processes can produce a reliable product. Quality As You See It has the experience in collecting, sampling, testing, analyzing and investigating out-of-specification events throughout your manufacturing processes. 

Quality Investigation

Unexpected events often happen throughout the manufacturing of a product. When initiating an investigation, the entire scope of the issue must be understood. A strong investigation system is needed in identifying an effective root cause, and in implementing corrective and preventive action(s). Quality As You See It can support your business in the preparation, investigation, evaluation, and assessment of relative pharmaceutical manufacturing issues encountered during the manufacturing, test, and inspection of your products. 

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