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Experiment # 4 Questions: 1 . Give the procedure for reading the volume in relation to the formation of the meniscus. 2. Give the USP specification and tolerances regarding liquid and solid filling. 3. What are the factors that may affect a product’s fill volume? Experiment # 5 Sampling and Sampling Plan 1. To determine the numbers required in a sampling plan. 2. To demonstrate the square root sampling plan. Compute for the following problems using the two sampling plan methods The following materials were delivered and received in the warehouse with a status of ready for sampling.

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Determine the number of samples to be taken (using both sampling plan) include the acceptance and rejection. Labels – 3 packs of 12 bundles by 500, 1 pack of 14 bundles by 500 Bottles 30 mL cap – 210 shippers X 144 Inserts – 55 packs by 500, 1 pack by 300 Cartons – 100 packs by 250 What is the sample size code letter for a lot of 30,000 bottles coming from a new supplier? What is the sample size using square root system? For an AQL of 0. 65, using normal inspection, determine the acceptance and rejection number. M315 AC-5 Re-6 A batch size of 25 was accepted where 3 defectives were found during the nspection.

The acceptance limit is 2. 5% defectives. Determine the sample size code letter, sample size, acceptance number and AQL using the master table. Give the N if the sample size is 5 using square root system. 1. Enumerate the materials to be sampled. 2. Site some advantages and disadvantages for each system of sampling plan. 3. Give the duration of time for keeping the following samples: Finished product- Reference and retention samples from each batch of finished product should be retained for at least one year after the expiry date. http://ec. europa. u/health/files/eudraleWvol-4/pdfs-en/2005_12_14_annex19_en. df Records/Documents- The duration of retention for pharmaceutical records has been the object of great debate among specialists from different areas. http:// www. arma. org/bookstore/files/stamatiadis. pdf I ne Issuance, revlslon, supersealng, ana wlt narawal 0T all documents snou10 De controlled, with maintenance of revision histories. When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents. Superseded documents should be retained for a specific period of time. *no specific time? ttp://www. ncbi. nlm. nih. ov/pmc/articles/PMC3122044/ Raw materials- Packaging materials- Experiment # 7 Moisture Permeation Test 1. To understand the importance of vapour transmission test. 2. To demonstrate a simple stability study for a packaging component. 3. To train the students in decision-making. 1 . Enumerate the different classes of containers. 2. Between glass-type and plastic type container, which has lower permeability? Explain. 3. What are the different storage conditions? 4. Other than moisture and temperature, name other factors, which may directly contribute the stability ofa product.


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