Batch Record Review CONTENT Package

An integrated package that includes a must read article, SOP, Audit Checklist, Form and powerpoint training presentation and trainer instructional notes. Package includes:

➢ 1. Batch Production Records - GMP Considerations: An Introduction (Article)

Click here to view complimentary excerpt

➢ 2. Batch Record Review SOP

➢ 3. Batch Record Review Audit Checklist

➢ 4. Quality Disposition Form

➢ 5. Batch Record Review Training (PowerPoint Training Presentation)

➢ 6. Batch Record Review Training (Trainer Instructional Notes)

1. Batch Production Records - GMP Considerations: An Introduction (Article)

Click here to view complimentary excerpt

This seven (7) page article provides introductory review of the fundamentals of batch production records, including the following subject matter content below:

➢Defining batch production records

➢Master batch record

➢11 pieces of critical information required for a batch record

➢GMP requirements for batch records

- 211.186

- 211.188

- 211.192

- 211.194

➢Sound documentation practice

- Appearance

- Sequence

- Consistency

- Completeness

➢Conducting an effective batch record review

➢Nine critical areas that must be reviewed and verified, including:

- Components

- Ingredients or charge in of components

- Manufacturing process

- Packaging operations

- …and more

2. Batch Record Review SOP

This six (6) page SOP contains 37 proposed actions which describe the process for review and approval of cGMP documentation for master production records and executed production records. This procedure applies to clinical and commercial documentation supporting cGMP activities, all batch record-related cGMP documentation received, commercial product, or clinical product purposes.

3. Batch Record Review Audit Checklist: Attachment 1

This three (3) page checklist contains 44 audit items related to batch record review, including:

➢ Master batch records

➢ All executed batch records

➢ Executed blister packaging records

➢ Executed bottle packaging records

➢ Executed label printing and labeling records

4. Quality Disposition Form: Attachment 2

One (1) page in length

5. and 6. Batch Record Review Training (PowerPoint Training Presentation & Trainer Instructional Notes)

This 30 page presentation provides a review of all critical regulatory, quality and procedural aspects to conducting effective batch record review practice. This document accompanies the Batch Record Review SOP.

Subject matter content includes:

➢cGMP regulations

➢Core cGMP values-quality

➢Batch record review forms a critical component of cGMP

➢Defining the batch production record

➢The master batch production record

➢The batch production record

➢Types of batch records

➢Good documentation practice

➢Reviewing other quality systems

➢Failure investigations/root cause analysis

➢21 CFR 211.192 product failure investigations

➢Investigation reports

➢Product specifications

➢OOS test results

➢Classifying deviations

➢Reprocessing

➢Disposition

➢FDA inspections-batch record controls

➢FD483s and investigations

Batch Record Review CONTENT Package is only $99.00 -