SOPs

LINE CLEARANCE FOR THE SUGAR MANUFACTURING AREA

ABHA

LINE CLEARANCE FOR THE SUGAR MANUFACTURING AREA

BMR is available & complete till Stage.

Check the “Status Board” of the area for the following details: Product Name, Batch No., Mfg. Date, Exp. Date, Batch Size, and match with BMR.

Verification of cleaning of light fixtures, return air risers, & supply air risers during line clearance at Sugar Mfg. area.

The waste bin is emptied out and cleaned.

Line Clearance for sugar mfg. area, verification of Preventive maintenance & Qualification status

All personnel are in required apparel viz. gowning, gloves, mask, and goggles. Pieces of jewelry etc. are removed

Status label of Equipment, the material is updated and released from QC. All required utensils and areas are visually cleaned

No activity (i.e. maintenance or other product handling) is being carried out in the area except mentioned in BMR/SOP.

Sodium Lamp is available for light-sensitive Material and is in working condition.

DATE (Date required in case of LC to be done in shift change or day of working change) 

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube