What are the Batch Records ?
STAGE II:
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 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 keep documents updated, if an organisation doesn't have enough technical persons.
We design a customised 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 entire documentation of manufacturing system and collect necessary documents for record preparation purpose from company with non disclosure agreement.
If documents were not available with company then consultant may suggest for further actions need to be taken.
Time for consultation: 5 days
STAGE II:
Work order for BMR Filling job and Refundable Security Deposit for One Year Agreement
STAGE III:
Daily Working Methodology:
- 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.
- 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.
Kindly mail us at sunconsultation@gmail.com for further inquiries.
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