calulation of yields, production record review,change control

just for an idea

1. SRIKRUPA INISTITUTE OF PHARMACEUTICAL SCIENCES (Approved by AICTE; PCI) (Affiliated to Osmania University)       ASSIGNMENT ON CALCULATION OF YIELDS, PRODUCTION RECORD REVIEW, CHANGE CONTROL     SUBMITTED BY HUZAIFA NAAZ

2. CALCULATION OF YIELDS PRDUCTION RECORD REVIEW CHANGE CONTROL CALCULATION OF YIELDS, PRODUCTION RECORD REVIEW, CHANGE CONTROL

3. THEORETICAL YIELD: The amount o f drug that is calculated by using balanced equation. ACTUAL VALUE: The amount of drug that is obtained when reaction takes place. PRACTICAL YIELD: It is the combination of both theoretical yield and actual yield i.e., Practical yield = theoretical yield x 100 actual yield CALCULATION OF YIELDS

4. All drug product production and control records including those for packaging and labelling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow up. Production record review

5. The USP has established that the acceptable range of most compounded preparations is typically +/- 10% ; however , it can be as great as +/- 20% (as with some proteins) or as tight as+/-5%(as with potent analgesics).for some raw powders, potency is required to be within +/-2%. In addition to 211.192 requires review and approval of all production records prior to batch release /distribution and unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated. CHANGE CONTROL DEFINITION: “ Change control is a formal system by which a qualified representative of appropriate disciplines review proposed and actual changes that might affect the validated status. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.” 21 cfr 211.192 PRODUCTION RECORD REVIEW

6. 1 – Minor change is a change that has minimal potential to have an adverse effect on identity, strength, quality , purity, or potency of the product as they may relate to the safety or effectiveness of the product . 2 – Major change is a change that has a moderate potential to have an adverse effect on the identity , strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product . 3- Critical change is a change that has a substantial potential to have an adverse effect on the identity , strength, quality, purity, or potency of a product as they may relate to the safety or effectiveness of the product. Types of Change control

7. “Level -1 signifies level of approval required to approve a change” Initiator department and the quality assurance department only e.g . SOPs related to single department like operating procedure of equipment’s, cleaning procedure of equipments , etc. “Level -2 signifies level of approval required to approve a change” Initiator department and all other interlinked departments within the plant e.g . Change in SOPs which are being followed at different departments at plant level. Levels of approval of Change control

8. “ Level -3 signifies level of approval required to approve a change” Initiator department and all other relevant departments (within plant or outside the plant) including marketing, RA and Quality and Compliance, etc. e.g . Change Controls which include change in specifications /STPs / GTPs / Artworks / License related issues / BMR / process change / Vendor change, etc These type of changes may require company’s R.A. department to ask for approval of regulatory agency( ies ) that have impact on regulatory dossiers submissions.

9. Fill the from Initiator department, date, Name & Designation and proposed hangs along with proper justification and assess the need of training Procedure of Change Control Any personnel can propose a change through “CHANGE CONTROL FORM” Head of initiator department shall assess the type of change and changes required in the interlinked documents and finally countersign on the proposal. Once the form has been signed by the initiator’s department head / designee, the same shall be forwarded to QA. QA personnel shall evaluate the basic requirements of the change control and assess whether change control requires comments / approval from Level 1/2/3. QA personnel allocates a unique number to the change control and log the same number in the “Record of Change Control”

10. Comments on the change control can be asked from out stationed departments through email/fax Procedure of Change Control After that QA personnel shall circulate the change control for approval to different department Heads or designee. All the Concern Department Heads/Designee shall evaluate the change control at their respective ends and give their comments and submit back to QA for further action plan. Head QA or Designee shall approve or reject the change controls based on the sound scientific assessment. After approval Head QA / designee, QA personnel shall send the change intimation to all concerned department heads / designee for planning the implementation of the change control through electronic means of communications. After approval of change control, QA Personnel shall evaluate the implementation of same and shall close the change control only after all documents or any activity mentioned in the change control is closed.

11. Documenting the change request Formal assessment of the change Proper Planning and timeline Final Impact assessment of the change Implementation of change Final assessment after Implementation Steps of change control

12. Documenting the change request: When any change is proposed, the request form is filled and change is categorized in minor, major, critical and recorded, along with informal assessments of the importance of that change and the difficulty of implementing it . Formal assessment of the change: The justification for the change and risks and benefits of making/not making the change are evaluated. If the change request is accepted, a change control review team will be assigned . If the change request is rejected , that fact is documented and communicated to the Initiator. Steps of change control

13. Proper Planning and timeline: The review team responsible for the change reviews approval or rejection, implementation and plans properly for its implementation within timeline . Final Impact assessment of the change: The review team does correct impact assessment of the change with respect to GMP. If the change is found to have no impact on GMP and it is improving for the system, then the review team requests approval and gives the timeline for implementation . Implementation of change: The review team also verifies the implementation status of the change after approval and the timeline of the change implementation. Final assessment after implementation: If the initiator, review team and QA are satisfied that the change was implemented satisfactorily, the change request is closed. Steps of change control