VIVIMED LABS LIMITED, BIDAR

VIVIMED LABS LIMITED,

GOOD DOCUMENTATION BIDAR
PRACTICES

GOOD DOCUMENTATION PRACTICES

K.RAM BABU
DY.Manager - QA,
VIVIMED labs, Unit – I,
Bidar.Karnataka.
 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

PRODUCT CHANGE OVER

BMR Indent LINE CLEARANCE

BMR ISSUE ENVIRONMENTAL MONITORING

HYGIENE
MATERIAL DISPENSING
GOOD MANUFACTURING PRACTICES

PRODUCTION GOOD LABORATORY PRACTICES

INPROCESS CONTROL

INTERMEDIATE CONTROL

FINISHED PRODUCT CONTROL

PRODUCT RELEASE

PRODUCT DISPATCH

GOOD MANUFACTURING PRACTICES

 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

• Objectives of the Good documentation

1. To review general requirements for
documents
2. To review specific requirements for each
document
3. To consider current issues applicable to
regulatory bodies (WHO, US FDA, MHRA)
 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

• Purpose of the Documentation

• Documentation is an essential part of the QA system
• Should exist for all aspects of GMP
• Defines specifications and procedures for all
materials and methods of manufacture and control
➤Ensures all personnel know what to do and when to do it
➤Ensure that authorized persons have all information
necessary for release of product
 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

• Purpose of the Documentation

➤Ensures documented evidence, traceability,
provide records and audit trail for investigation
➤Ensures availability of data for validation, review
and statistical analysis
 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

Why documents are so important?

• Communication
• Cost
• Audit trail
• Regulatory requirements
 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

BATCH MANUFACTURING RECORD (BMR)

Record kept for each batch processed
• Check suitability of area and equipment
➤ clear of previous products, documents, materials
• In process Checks recorded
 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

BATCH MANUFACTURING RECORD (BMR)

Information recorded during processing :
• Name of the product, batch number
• Dates and times (e.g. start, major steps, completion)
• Name of person responsible for each stage of production
• Name of operators carrying out each step (check signatures)
• Cross checked signatures (Shift In charges)
• Theoretical quantities for materials in the batch
• Reference number and quantity of materials used in the batch
 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

BATCH MANUFACTURING RECORD (BMR)

• Main processing steps and key equipment
• In-process controls carried out, person's initials, and
results obtained
• Yield at each stage with comments on deviations
• Expected final yield with acceptable limits
• Comments on any deviations from process
• Area clearance check, instructions to operators
• Record of activities (Deviations, Process Delays)
 VIVIMED LABS LIMITED, BIDAR
GOOD DOCUMENTATION PRACTICES

BATCH MANUFACTURING RECORD (BMR)

Review of BMR by Production

Submission of BMR to QA
Review of BMR QA
Review of All Analytical Data by QA
Release of Finished Product by QA