quality assurance of raw materials, API,finished &packaging material

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QUALITY ASSURANCE OF RAW MATERIALS,API,FINSHED &PACKAGING MATERIALS: 

QUALITY ASSURANCE OF RAW MATERIALS,API,FINSHED &PACKAGING MATERIALS PRESENTED BY: M.SWETHA M PHARMACY I YEAR PHARMACEUTICS UNDER THE GUIDANCE OF SANTHOSH KUMAR SIR SRIKRUPA INSTITUTE OF PHARMACEUTICAL SCIENCES

CONTENTS: 

CONTENTS DEFINITION OF QA SORUCE OF QUALITY VARIATION QA OF RAW MATERIALS QA OF API QA OF FINISHED PRODUCT QA OF PACKAGING MATERIAL 2

QUALITY ASSURANCE: 

QUALITY ASSURANCE DEFINITION : Quality assurance is defined as assurance of product quality depends on more than just proper sampling & adequete testing of various components &the finished dosage form. Covers everything from raw materials and GMP verification through finished-product release QUALITY CONTROL Actual manufacturing process 3

What is Quality: 

What is Quality The ability to make the same thing the same way, over and over again Customer buys today is same as what they bought last week or will buy next week Product meets customer’s expectations 100% of the time 4

Quality systems : 

Quality systems Objectives To prevent risks To detect deviations To correct errors To improve efficiency To reduce costs How : By establishing a quality manual defining Organizational structure – Staff Responsibilities Procedures and processes Resources Documentation 5

The 5M’s of Quality: 

The 5M’s of Quality Man Material Machinery Manuals/Methodology ( SOP) Motivation 6

Factors influencing quality:: 

Factors influencing quality: 7

SOURCES OF QUALITY VARIATION: 

SOURCES OF QUALITY VARIATION Material Equipment Environment Process Person ( 40-70% ): more quality deviation. 8

RAW MATERIALS : 

RAW MATERIALS It is basically the chemical ingredients of a process. Basic raw materials are starting material , which is used in production of final product. Good raw material specifications must be written in precise terminology, must be complete, must provide specific details of test methods, type of instruments, and manner of sampling, and must be properly identified . 9

QA OF RAW MATERIALS: 

QA OF RAW MATERIALS 1. Active or Therapeutic Materials 2 .Active material other than antibiotics 3 . Modified specification for tablets 4. Modified specification for parenteral system 5. Raw material quality assurance monograph 10

1. ACTIVE OR THERAPEUTIC MATERIALS : 

1. ACTIVE OR THERAPEUTIC MATERIALS Testing of antibiotics is usually performed either physicaly , chemically , microbiologically, or by all three methods Sampling procedure must be done in special condition. Assay for potency of antibiotic raw materials must be carefully achieved . 2. ACTIVE MATERIAL OTHER THAN ANTIBIOTICS Specifications normally include solubility, identification, melting range, loss on drying, residue on ignition, special metal testing. Raw materials can evaluated and controlled with special instrumentation In general, a typical raw material currently found in a compendium has a purity requirement of at least 97%. 11

3. Modified specification for tablet: 

3. Modified specification for tablet In the development of raw material specifications, the analytical research and development chemists should strive for the following: Ascertain which chemical, physical and biological characteristics are critical for assuring reproducibility from lot-to-lot of raw material to be used for evaluating each lot of raw material produced or purchased . Specification: - Nonvolatile residue - Particle size - Ash - Polymorphic forms - Acid-insoluble ash - Crystallinity characteristic - Loss on drying - Water content 12

4.Modified specification for parenteral system : 

4.Modified specification for parenteral system Great number of potential sources of contamination, strict sanitation of plant warehouse is an absolute necessity. Microbial flora is usually associated with raw materials from natural sources where as synthetic raw materials are normally free or low in microbial contamination. A sterilization procedure may include heat treatment, radiation or recrystallization from a bactericidal solvent, such as alcohol. Specifications: -Color -Powder fineness or density -Solvent - Microbial count -Sterility - Pyrogen 13

5. Raw material quality assurance monograph : 

5. Raw material quality assurance monograph A. Name of Raw Material: 1 . Structural formula, molecular weight 2. Chemical name(s) 3. Item number 4 . Date of issue 5. Signature of writer 6 . Signature of approval B . Samples: 1. Safety requirement 2 . Sample plan and procedure 3 . Sample size and sample container to be used 4 . Preservation sample required 14

C. Retest Program: 1. Retesting schedule 2. Reanalysis to be performed to assure identity, strength, quality and purity. : 

C . Retest Program: 1 . Retesting schedule 2. Reanalysis to be performed to assure identity, strength, quality and purity. D. Specifications (wherever applicable) 1 . Description 2 . Solubility 3 . Identity: a. Thin-layer, paper, liquid, or gas chromatography b. Infrared absorption c. Ultraviolet absorption d. Melting range e. Boiling point or range 15

PowerPoint Presentation: 

4 . Purity and quality a. pH, specific rotation, nonvolatile residue, ash, acid-insoluble ash , residue on ignition, loss on drying, water content, heavy metals, sulfate, chloride, carbonates, acid value, saponification value. b. Special quality tests - particle size, crystallinity characteristics, and polymorphic forms 5 . Assay calculated either on anhydrous or hydrous basis 6. Microbial limits especially for raw materials from natural sources 16

E. Test procedure 1. C ompendial , USP or NF references 2. N oncompendial , detailed analytical procedures, weights; dilutions, extractions, normality, reagents, instrumentation used and procedures, if any calculations F. Approved suppliers 1. List of prime suppliers and other approved suppliers 17

Sampling: : 

Sampling: Number of containers of raw materials to be sampled per lot Containers No. samples 1-5 All 6-10 6 11-18 7 19-28 8 29-100 9 >101 10 18

STANDARD OPERATING PROCEDURES (SOPs): 

STANDARD OPERATING PROCEDURES (SOPs) Standard operating procedures describe in a detailed form the activities performed in the laboratory Provide uniformity, consistency and reliability in each of the activities performed in the laboratory Reduce systematic errors Provide training and guidance for new staff Written instructions that specify how a test or procedures is to be performed. How a piece of equipment is operated, maintained and calibrated. 19

Describes “Standard” approved procedures. Revision when planned changes are made or annually : 

Describes “Standard” approved procedures . Revision when planned changes are made or annually Original – maintained in a central file. Copies – distributed to locations. Written by the person performing the procedure or who knows the procedure well. Supervisor review SOPs for completeness and content. QA or QC staff approval 20

Format of an SOP: 

Format of an SOP Title : descriptive Code : Number relating to procedure and revisions Objective : Aim of the procedure clearly described Scope : The operating unit and field of application Definitions : Meaning of principle terms used Description : Operating instructions clearly described without any ambiguity, understood by all staff with flow diagrams Safety : Measures to be kept in mind when executing the SOP Documentation : Protocol, Data sheets and measurements References : Used to draw up the SOP 21

Format on each page of SOP: 

Format on each page of SOP Logo and name of the organization Department or unit issuing the SOP Title and date of issue Signature of person who drew up the SOP Signature of person who reviewed it Signature of person who authorized it Duration of validity Date of review Code Page number and total number of pages in the document 22

QA OF FINISHED PRODUCTS: 

QA OF FINISHED PRODUCTS Specifications Appearance, odor, color, taste Hardness DT Friability Thickness uniformity Assay of active ingredient Moisture content Light stability Identification tests Content uniformity Dissolution Microbial limits Stability 23

QA OF PACKAGING MATERIALS: 

QA OF PACKAGING MATERIALS P rimary packaging: Packaging material directly contact with product. S econdary packaging: It is between the product &atmosphere. Tertiary packaging: It contact with atmosphere . 24

Packaging form carries : 

Packaging form carries Name of the product Item number Lot number Number of labels Inserts Packaging materials to be used Operations to be performed & Quantity to be packaged 25

REFERENCES:: 

REFERENCES: T he T heory and Practice of Industrial Pharmacy by L eon L achman & L ibermann 26

PowerPoint Presentation: 

Thank you