Author: Abha Maurya

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies”

Posted on By Abha Maurya

GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies” The GMP Deficiencies findings of a Good Manufacturing Practice (GMP) inspection can have a substantial impact on both your organization and, subsequently, public health. If the GMP Deficiencies found are classified as significant, they may necessitate cessation of manufacturing activities and/or product withdrawal from the market. In the advent of…

Read More “GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies”” »

Quality Assurance

Isolators In Pharma Industry

Posted on By Abha Maurya

Isolators In Pharma Industry Isolators are clean air devices providing complete separation between an aseptic process (hazardous/non-hazardous), the technical personnel, and the surrounding work environment. Isolators are generally used in applications requiring a high degree of protection from external elements or contaminants, and they can serve as alternatives to sophisticated cleanrooms. Isolators typically feature built-in…

Read More “Isolators In Pharma Industry” »

Production, Microbiology

Cleaning of Dispensing Area during Product Changeover

Posted on By Abha Maurya

Cleaning of Dispensing Area during Product Changeover The area cleaning during Product Changeover: Start the cleaning operation of the ceiling and then to walls from top progressing to downwards. Clean the door and window glasses using a wet duster soaked with disinfectant solution. Clean the doors, door closure handles, and all the hinges of the…

Read More “Cleaning of Dispensing Area during Product Changeover” »

Warehouse

Inspection, Sampling and Storage of Packing material

Posted on By Abha Maurya

Inspection, Sampling, and Storage of Packing material Receipt and Inspection of Packing material Containers Upon receipt of packing material, the same shall be placed in the quarantine store attached to the Packing Material Store. In-charge of the Packing Material Store shall inform the QC Department for the inspection of containers and taking of samples for…

Read More “Inspection, Sampling and Storage of Packing material” »

Warehouse

Handling of Spillage of Materials

Posted on By Abha Maurya

Handling of Spillage of Materials Procedure Spillage of any material shall be handled immediately when observed and effectively as per the procedure mentioned below  : The personnel working in the concerned department shall immediately inform the Incharge of the concerned department about the spillage of material. The concerned department Incharge shall inform QA about the…

Read More “Handling of Spillage of Materials” »

Warehouse

Entry & Exit procedure in warehouse area

Posted on By Abha Maurya

Entry & Exit procedure in the warehouse area Push the door of the primary changing room and enter the room. Remove your street footwear and unwanted articles like wristwatches, ornaments, etc., and keep them in respective lockers. Sanitize your feet by using a soak system having disinfectant. Cross the cross-over bench (COB) as displayed in…

Read More “Entry & Exit procedure in warehouse area” »

Warehouse

Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production

Posted on By Abha Maurya

Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production Procedure On the receipt of the requisition slip from the concerned production personnel for the manufacture of a product, the store In-charge shall ensure that the requisition slip bears the signatures of all the concerned persons. The packing Material store…

Read More “Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production” »

Warehouse

Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store

Posted on By Abha Maurya

Cleaning of Raw Material Store, Packing  Material Store and Finished Goods Store Procedure Collect all the waste material, dust settled over tables, floors, containers, furniture, fixtures & walls with the help of a vacuum cleaner. Clean the door, window glasses, door closures, handles, and all the hinges of the door using a clean dry duster…

Read More “Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store” »

Warehouse

Dispensing of raw materials and transfer of dispensed materials from RM store to Production

Posted on By Abha Maurya

Dispensing of raw materials and transfer of dispensed materials from RM store to Production Pre-start-up activity for dispensing & Issuance of Raw material: On the receipt of the requisition slip from the production department for the manufacture of a product, the store personnel shall ensure that the requisition slip bears the signature of all the…

Read More “Dispensing of raw materials and transfer of dispensed materials from RM store to Production” »

Warehouse

Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis

Posted on By Abha Maurya

Stock Rotation of Raw Materials, Packing Materials, and Finished Goods on the “First-in, First-out” basis Objective To lay down a procedure to ensure proper stock rotation of Raw materials, Packing Materials, and Finished Goods so that the stock rotation of the materials may be on the “First-in, First-out” basis. Scope This Standard Operating Procedure is…

Read More “Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis” »

Warehouse

Inventory Control of Materials and Components

Posted on By Abha Maurya

Inventory Control of Materials and Components Procedure Raw Material Store, Packing Material Store and Finished Goods Store shall maintain proper records with respect to the Inventory Control of Materials and Components. Inventory Control regarding Raw Materials:-The following records shall be maintained by the Incharge of the Raw Material Store in which necessary inventories shall be…

Read More “Inventory Control of Materials and Components” »

Warehouse

ELECTRONIC RECORDS

Posted on By Abha Maurya

ELECTRONIC RECORDS  Scope (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b) This part applies to records in electronic form that…

Read More “ELECTRONIC RECORDS” »

Quality Assurance

Water Analysis as per IP/BP/USP

Posted on By Abha Maurya

Water Analysis  as per IP/BP/USP Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the water sample for the analysis. The precautions taken to avoid contamination must be…

Read More “Water Analysis as per IP/BP/USP” »

Quality Control

RESOURCES-THE QUALITY SYSTEMS MODEL

Posted on By Abha Maurya

RESOURCES-THE QUALITY SYSTEMS MODEL Appropriate allocation of resources is key to creating a robust quality system and complying with the CGMP regulations. This section discusses the role of resources in developing, implementing, and managing a robust quality system that complies with CGMP regulations. 1. General Arrangements Under a robust quality system, sufficient resources should be…

Read More “RESOURCES-THE QUALITY SYSTEMS MODEL” »

Quality Assurance

MANUFACTURING-THE QUALITY SYSTEMS MODEL

Posted on By Abha Maurya

MANUFACTURING-THE QUALITY SYSTEMS MODEL Significant overlap exists between the elements of a quality system and the CGMP regulation requirements for manufacturing operations. It is important to emphasize again that FDA’s enforcement programs and inspectional coverage remain based on the CGMP regulations. When quality system elements in this section do not correlate to the CGMP regulations,…

Read More “MANUFACTURING-THE QUALITY SYSTEMS MODEL” »

Quality Assurance

MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL

Posted on By Abha Maurya

MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL The goal of this section is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe the…

Read More “MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL” »

Quality Assurance

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS

Posted on By Abha Maurya

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS Several key concepts are critical for any discussion of modern quality systems. The following concepts are used throughout this guidance as they relate to the manufacture of pharmaceutical products. A. Quality Every pharmaceutical product has established identity, strength, purity, and other quality characteristics designed to ensure the…

Read More “CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS” »

Quality Assurance