SOP for IN-PROCESS CONTROL OF DRY SYRUP FILLING.

 1.0        OBJECTIVE             :   

Production of a good quality beta lactum products are achieved only when strict in-process controls are exercised while filling. Failure to adhere to process control norms while filling preparations may lead to many problems like color changing, stickiness of the product, weight variation of filled products etc.

 

2.0        SCOPE:

This procedure is applicable for the in process control while the ongoing operation of filling in beta lactum department at any pharmaceutical industry.

 

3.0        RESPONSIBILITY   :                                                                                   

·         Officer/Executive of production department shall be responsible to check the compliance regarding area/equipment before calling QA person for area and equipment line clearance

·         Officer/Executive QA shall be responsible to verify the compliance regarding area/equipment before giving the clearance for to start the process.

 

4.0        ACCOUNTABILITY           :

Head of the department

 

5.0        PROCEDURE                    

5.1        The materials are used for manufacturing purpose must meet the standards.

5.2        Raw materials used for manufacturing purpose are all approved materials and having approved labels fixed on it.

5.3        Physical characteristics of raw material like colour, odor consistency are checked before  compounding raw materials  having  a factor of moisture should be consider if requirement as per BMR before use.

5.4        Weighed raw material by store officer should be counter checked by pharmacist. If any discrepancy is noted it should be immediately brought to the notice of factory manager.

5.5        pH of product should be checked before filling and after filling.

5.6        Physical description of the final product should meet the standard.

Equipment and machinery used for filling and capping should be thoroughly checked and adjust as per requirement.