SOP on Planning and Handling of Exhibit batches and Placebo batches
Objective : To lay down a procedure for Planning and Handling of Exhibit batches and Placebo Batches.
Scope : This Standard Operating Procedure is applicable for formulation plant.
Responsibility : Executive / Supervisor – Production and PDL personnel shall plan the manufacture of Exhibit batches and Placebo batches and make provision for proper segregation and storage in the designated area.
R & D and PDL person shall be responsible for the preparation of protocols for Placebo batches.
R&D and PDL shall be responsible to provide all support for documentation, required during manufacture of Placebo batches
QA Executive/ Officer shall be responsible for the preparation of protocols for Exhibit batches
QA Executive/ Officer shall be responsible for assigning number to Authorization note.
QA Executive/Officer shall be responsible to provide all support for documentation, required during manufacture of Exhibit batches.
IPQA shall be responsible for sampling of different stages of Placebo or Exhibit batches and assurance of cGMP standards during the manufacturing of Exhibit batches and Placebo batches.
Officer/Executive–Production shall be responsible for filling the information in Authorization Note
Head- Production shall be responsible for implementation of this SOP.
Head – QA/ designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions
Exhibit Batches – Exhibit batches are the pivotal batches which are used to support formal stability studies, pre-clinical and clinical evaluation. Manufacturing documents of exhibit batches are used for filing in the regulatory agencies.
Placebo Batches – Placebo batches are manufactured for its use in analytical method validation and formal stability study.
Procedure :
EXHIBIT BATCHES :
After completion of Optimization batches PDL personnel shall submit the Optimization report to QA for final approval.
After approval of Optimization report, Executive/Officer –QA shall prepare the protocols for exhibit batches. Head-QA finally approves the protocol.
Head-Production in consent with store, R&D, PDL and QA shall plan for manufacture the exhibit batch.
QA shall access the pre-requisites for taking exhibit batches and accordingly finalize the date for taking exhibit batch. These pre-requisites shall be filed in a file containing pre-requisites for all the products manufactured at formulation plant, Baddi.
Exhibit batch shall be manufactured as per their respective protocols prepared by QA.
Executive/Officer production shall assign the manufacturing date and expiry date to the exhibit batch.
Manufacturing date shall be given as per SOP and expiry date shall be given as per the tentative shelf life of the product as mentioned in MFC.
Note: – Shelf life is tentative, actual shelf life shall be re-ascertained based on real time stabilities studies.
Active pharmaceutical ingredients which shall be issued for manufacture of exhibit batches should be from different AR No. / Batch No.
After packaging, the exhibit batches shall be staged in the Exhibit sample room with lock and key arrangements and under controlled environmental conditions.
After completion of exhibit batches Executive /Officer –QA shall prepare exhibit report.
PLACEBO BATCHES
Note : – Placebo batches for analytical purpose shall be prepared and formula and process details shall be maintained in laboratory note book. Placebo batches for clinical studies shall be prepared with relevant documents.
All documents required for manufacturing of placebo batches shall be submitted by R&D to Documentation Cell-QA.
Head-Production in consent with stores, R&D, PDL and QA shall plan the manufacturing of placebo batches.
Executive/Officer –production shall assign the manufacturing date and expiry date to the placebo batches.
After packaging, the placebo batches shall be staged in the Exhibit sample room with lock and key arrangements under controlled environmental conditions or destroyed (As per requirement).
Destruction of placebo batches shall be done in accordance with destruction SOP.
A Sample requisition form shall be raised by concerned department personnel and shall be authorized by Head-QA prior to withdrawal of the sample from the controlled area and the information regarding the issuance shall be recorded in Sample Log Book by IPQA personnel.
The Material Destruction Note (MDN) numbering of destruction note shall be given as per reference of SOP.
Production department shall raise a request in detail in case of conversion of Optimization, Exhibit and Commercial batches to Batches with different Packaging Batch Number or use of other packaging components other than specified in TD’s or Protocol etc duly signed by Production Head. And submit to QA for further action.
Authorization Note :
On receiving the Request of Production, an Authorization note shall be raised by QA for the following reason :
For conversion of Optimization batches, exhibit batches and other commercial batches to batches with different Packaging Batch Number.
Use of packaging components other than those specified in the technical direction or optimization protocol etc. which shall not affect quality of the finish product.
Authorization note prepared shall be given numbering as ANXXX/YY where 1st &2nd character stand for Authorization note, 3rd,4th& 5th character denote the serial number of Authorization note as per financial year, 6th character shall denote a dash, 7th & 8th character shall denote financial year for e.g. first Authorization note for the financial year April 2025 to March 2026 shall be given numbering as AN001/25.
Authorization note shall be sent to all concerned departments for approval. After getting the approval from concerned departments the authorization note shall be forwarded to Head-Production for his authorization and finally sent to Head-QA for authorization.
After Approval of Authorization note by Head-QA, a copy of the Approved Authorization note shall be send to QC, Logistic, and Marketing & Stores for there Reference & Records.