What are the Batch Records?

The Batch Record is the most crucial archived document in a Pharmaceutical Company, It plays a crucial role in monitoring processes, initiating investigations and CAPA’s, in the Annual Product Review, and always be a key issue in regulatory inspections.

Hopefully, there won’t be a problem with the marketed product; but if and when a disaster occurs, the batch record is where the investigation begins…

• Batch Manufacturing Record
• Batch Packing Record
• Machine Log Book
• Batch Manufacturing Register

It is mandatory to keep documents updated if an organization doesn’t have enough technical persons.

We design a customized Batch Manufacturing/Packing Record for all categories of Ayurvedic Pharmaceutics.

STAGE I:

One Time Document Validation Consultation:

Before commencing Batch Manufacturing one time documentation validation consultation is mandatory. In which our expert will inspect the entire documentation of the manufacturing system and collect necessary documents for record preparation purposes from a company with a nondisclosure agreement.

If documents were not available with the company then the consultant may suggest further actions need to be taken.

Time for a consultation: 5 days

STAGE II:

Work order for BMR Filling job and Refundable Security Deposit for One Year Agreement

STAGE III:

Daily Working Methodology:

• The company has to just send us true details as below via email.
• Product Name, Batch No., Batch Size, Manufacturing Date, Expiry Date, Total Number of Units Packed in which Packaging.
• As per product information out team will prepare documents with validated batch loss and send a copy of Records through email.
• The company needs to just print and sign in all records for filing, this would be a daily activity.
• Monthly per batch the service charges will be billed.