Good warehousing practices

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utkarsha shivsharan

It describes the Good warehousing practices for pharmaceuticals.

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GOOD WAREHOUSING PRACTICES
Presentation by
Miss Utkarsha Sukhdev Shivsharan
M.Pharm (Quality Assurance)
Assistant Professor
DSTSM’s College of Pharmacy, Solapur

Introduction
• API
• Contamination
• Cross-contamination
• Excipient
• Expiry Date
• Labelling
• Manufacture
• Packaging Material
• Pharmaceutical
Product
• Production
• Retest Date
• Storage
• Supplier

Storage Conditions
Monitoring Of Storage Conditions
Documentation
Labeling & Containers
Receipt

Returned Goods
• Recalled goods
• Return to saleable
stock
• Destroy
Dispatch & Transport
• Maintainance of
storage conditions
• Safety precautions
• Monitoring of
conditions
• Dispatch after receipt
• Dispatch procedures
• Records
Product Recall

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Presentatio on IPQC for Capsules by Akshay Trivedi Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements".[1] This approach places an emphasis on three aspects (enshrined in standards such as ISO 9001)[2][3]: Elements such as controls, job management, defined and well managed processes,[4][5] performance and integrity criteria, and identification of records Competence, such as knowledge, skills, experience, and qualifications Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.[3] The quality of the outputs is at risk if any of these three aspec Modern humans are distinguished from other species by their extensive use of tools to control and adapt to their surroundings. Early stone tools such as anvils had no holes and were not designed as interchangeable parts. Mass production established processes for the creation of parts and system with identical dimensions and design, but these processes are not uniform and hence some customers were unsatisfied with the result. Quality control separates the act of testing products to uncover defects from the decision to allow or deny product release, which may be determined by fiscal constraints.[6] For contract work, particularly work awarded by government agencies, quality control issues are among the top reasons for not renewing a contract.[7] The simplest form of quality control was a sketch of the desired item. If the sketch did not match the item, it was rejected, in a simple Go/no go procedure. However, manufacturers soon found it was difficult and costly to make parts be exactly like their depiction; hence around 1840 tolerance limits were introduced, wherein a design would function if its parts were measured to be within the limits. Quality was thus precisely defined using devices such as plug gauges and ring gauges. However, this did not address the problem of defective items; recycling or disposing of the waste adds to the cost of production, as does trying to reduce the defect rate. Various methods have been proposed to prioritize quality control issues and determine whether to leave them unaddressed or use quality assurance techniques to improve and stabilize production.[6] Notable approaches

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The principal objective of dosage form design is to achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. To ensure product quality, numerous features are required, like chemical and physical stability, suitable preservation against microbial contamination if appropriate, uniformity of dose of drug, acceptability to users including prescriber and patient, as well as suitable packing, labeling, and validation1 . Process validation establishes the flexibility and constraints in the manufacturing process controls in the attainment of desirable attributes in the drug product while preventing undesirable properties. This is an important concept, since it serves to support the underlying definition of validation, which is a systematic approach to identifying, measuring, evaluating, documenting, and re-evaluating a series of critical steps in the manufacturing process that require control to ensure a reproducible final product.3 USFDA defined process validation as “establishing documented evidence which provides high degree of assurance that a specific process will consistently produce a product meeting its pre determined specifications and quality characteristics.”5 Solid dosage forms include tablets and capsules. The manufacturing of solid dosage forms involves extensive powder handling. The powder must be blended for uniformity and converted into the dosage form either through compression or encapsulation. Typical requirements include weighing, blending, mixing/granulation areas, compression/encapsulation areas, and coating areas. 2 Despite the ongoing development of more sophisticated solid drug delivery systems, tablets are still by far the most prevalent solid dosage form. The emphasis will be on the practical inspectional requirement, rather than on a theoretical approach that does not reflect the practicalities (and problems) encountered when validating actual production operations. A tablet is a pharmaceutical dosage form. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted into a solid. The excipients can include binders, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrants to promote tablet break-up in the digestive tract; sweeteners or flavors to enhance taste; and pigments to make the tablets visually attractive. A polymer coating is often applied to make the tablet smoother and easier to swallow, to control the release rate of the active ingredient, to make it more resistant to the environment (extending its shelf life), or to enhance the tablet's appearance

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