Review of pharmaceutical product, packaging and ich

Review of stability of packaged material like containers and closures.
The whole ppt is regarding the test perform to know the stability of a container which is used for product storage.
It also contain the guidelines of ICH.

1. : Recreated and edited by Deepak Shukla 3 rd B.Pharm , I.C.P.R Review of P harmaceutical product, packaging and ICH guidelines

2. Packaging is nothing but the proper storage of enclosing or protecting products for distribution, sale, and use from the time of production. Important factor Protects the product Safety Usability Displays and promotes the product Attracts buyers Sustainability What is packaging?

3. The purpose is to provide proper evidence on how the quality of a package varies with time under influence of variety of environmental conditions such as: Temperature Humidity Light Shelf life Storage conditions Purpose of stability testing

4. STABILITY TESTING Stability testing of pharmaceutical products is a complex set of procedures involving considerable cost, time consumption and scientific expertise in order to build in quality, efficacy and safety in a drug formulation . The most important steps during the developmental stages include pharmaceutical analysis and stability studies that are required to determine and assure: the identity, potency and purity of ingredients, as well as those of the formulated products.

5. STABILITY TESTING CONT. Stability testing is termed as a complex process because of involvement of a variety of factors influencing the stability of a pharmaceutical product. These factors include: Stability of the active ingredient(s); interaction between active ingredients and excipients, manufacturing process followed, type of dosage form, container/closure system used for packaging. Light, heat and moisture conditions encountered during shipment, storage and handling.

6. STABILITY TESTING CONT. Stability testing is a routine procedure performed on drug substances and products and is employed at various stages of the product development. In early stages, accelerated stability testing (at relatively high temperatures and/or humidity) is used in order to determine the type of degradation products which may be found after long-term storage. Testing under less rigorous conditions i.e. those recommended for long-term shelf storage, at slightly elevated temperatures is used to determine a product's shelf life and expiration dates.

7. AIM The major aim of pharmaceutical stability testing is: To provide reasonable assurance that the products will remain at an acceptable level of fitness/quality throughout the period during which they are in market place available for supply to the patients. And will be fit for their consumption until the patient uses the last unit of the product.

8. PHARMACEUTICAL PACKAGE STABILITY TESTING Compression Strength Testing : Provide a comprehensive report with data on the strength of a package. Distribution Simulation Testing : Packages experience many different forces during the shipping an distribution process. It is the product manufacturer's responsibility to evaluate and document the ability of the package to withstand the distribution and storage environments. Package Integrity Testing : It uses established tests to test the integrity of a pharmaceutical package, Such tests include dye leak, visual inspection, vacuum leak and bubble leak testing to inspect the package integrity capabilities.

9. Package Strength Testing : Package strength testing is conducted to measure and ensure that the components of the package will not separate when specific forces are applied. The testing of flexible components such as pouches, seal peel or burst testing are methods used to prove the packages strength. Vibration Testing : Packages and products experience a wide range of dynamic forces and stresses during distribution that could harm a product. It performs vibration tests on samples to simulate the stresses and forces a package/product would experience during the distribution process. Shock and Vibe Testing : Dropping, rotational edge dropping and rotational flat drop tests to simulate real world exposure of the package to shock forces by forklifts, package handling or other factors in the distribution cycle.

10. 1) CLIMATIC ZONES FOR STABILITY TESTING For the purpose of stability testing the whole world has been divided into four zones (I- V) depending upon the environmental conditions the pharmaceutical products are likely to be subjected during their storage. These conditions have been turned on the basis of the mean annual temperature and relative humidity data in these region

11. 2) Test schedule for stability testing

12. 3) Stability test for storage condition for product

13. ORIENTATION OF STORAGE OF CONTAINER Samples of the solutions, dispersed systems and semi solid drug products for stability studies must be kept upright and positioned either inverted or on the side to allow for full interaction of the product with the container- closure. This orientation helps to determine whether the contact between the drug product or solvent and the closure results in the extraction of chemical substances from the closure components or adsorption of product components in to the container- closure.

14. TEST PARAMETERS The stability test protocol should define the test parameters that would be used for evaluation of the stability samples. The tests that monitor the quality, purity, potency, and identity which could be expected to change upon storage are chosen as stability tests. Therefore appearance, assay, degradation products, dissolution, microbiological testing, and moisture are standard tests performed on stability test samples. Microbiological tests include sterility, preservative efficacy and microbial count as applicable e.g. for liquid injectable preparations. The batches used for stability study must meet all the testing requirements including heavy metals, residue on ignition, residual solvents.

15. PRESENTATION AND RECORDING OF STABILITY DATA Stability data is recorded in an organized, comprehensive and cumulative format. The stability data table is the means for reporting the results of the stability study in a concise format for ease of review and interpretation. The data is recorded in a proper tabular format. In addition, a graphical presentation of stability data versus time for the test data can be used to illustrate trends in data and may be helpful for data evaluation.

16. ICH ICH stands for “International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use”. ICH GUIDELINES The guidelines of ICH are broadly categorized into four types. 1) Quality guidelines 2) Safety guidelines 3) Efficacy guidelines. 4) Multidisciplinary guidelines

17. OBJECTIVES OF ICH Promote public health by early availability of drug in the market. Maintaining safeguards on quality, safety and efficacy. Improve efficiency of new drug development Reduce registration cost. Less expensive drugs for patients.

18. QUALITY GUIDELINES Q1A - Q1F :Stability Q2 : Analytical Validation Q3A - Q3D : Impurities Q4 - Q4B : Pharmacopoeias Q5A - Q5E : Quality of Biotechnological Products Q6A- Q6B : Specifications Q7 : Good Manufacturing Practice Q8 : Pharmaceutical Development Q9 : Quality Risk Management Q10 : Pharmaceutical Quality System Q11 : Development and Manufacture of Drug Substances Q12 : Lifecycle Management Q13 : Continuous Manufacturing of Drug Substances and Drug Products Q14 : Analytical Procedure Development

19. SAFETY GUIDELINES S1A - S1C : Carcinogenicity Studies S2 : Genotoxicity Studies S3A - S3B : Toxicokinetics and Pharmacokinetics S4 : Toxicity Testing S5 : Reproductive Toxicology S6 : Biotechnological Products S7A - S7B : Pharmacology Studies S8 : Immunotoxicology Studies S9 : Nonclinical Evaluation for Anticancer Pharmaceuticals S10 : Photosafety Evaluation S11 : Nonclinical Pediatric Safety

20. EFFICACY : The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics / genomics techniques to produce better targeted medicines. It includes E1- E18 guidelines MULTIDISCPLINARY : These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI). It includes M1- M10 guidelines.